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Gastroenterology

January 2024

Hirano I, et al; ASCENT WORKING GROUP. Ascending to New Heights for Novel Therapeutics for Eosinophilic Esophagitis. Gastroenterology. 2024 Jan;166(1):1-10. doi: 10.1053/j.gastro.2023.09.004. Epub 2023 Sep 9. PMID: 37690772; PMCID: PMC10872872.

Åkerström JH, et al. Antireflux Surgery Versus Antireflux Medication and Risk of Esophageal Adenocarcinoma in Patients With Barrett’s Esophagus. Gastroenterology. 2024 Jan;166(1):132-138.e3. doi: 10.1053/j.gastro.2023.08.050. Epub 2023 Sep 9. PMID: 37690771.

Barnes EL, et al; AGA Clinical Guidelines Committee. AGA Clinical Practice Guideline on the Management of Pouchitis and Inflammatory Pouch Disorders. Gastroenterology. 2024 Jan;166(1):59-85. doi: 10.1053/j.gastro.2023.10.015. PMID: 38128971.

February 2024

Yoo HW, et al. Helicobacter pylori Treatment and Gastric Cancer Risk After Endoscopic Resection of Dysplasia: A Nationwide Cohort Study. Gastroenterology. 2024 Feb;166(2):313-322.e3. doi: 10.1053/j.gastro.2023.10.013. Epub 2023 Oct 18. PMID: 37863270.

Yang J, et al. High Soluble Fiber Promotes Colorectal Tumorigenesis Through Modulating Gut Microbiota and Metabolites in Mice. Gastroenterology. 2024 Feb;166(2):323-337.e7. doi: 10.1053/j.gastro.2023.10.012. Epub 2023 Oct 18. PMID: 37858797.

Young E, et al. Texture and Color Enhancement Imaging Improves Colonic Adenoma Detection: A Multicenter Randomized Controlled Trial. Gastroenterology. 2024 Feb;166(2):338-340.e3. doi: 10.1053/j.gastro.2023.10.008. Epub 2023 Oct 14. PMID: 37839498.

Clinical Gastroenterology and Hepatology

January 2024

Overbeek KA, et al; Dutch Familial Pancreatic Cancer Surveillance Study work group. Intraductal Papillary Mucinous Neoplasms in High-Risk Individuals: Incidence, Growth Rate, and Malignancy Risk. Clin Gastroenterol Hepatol. 2024 Jan;22(1):62-71.e7. doi: 10.1016/j.cgh.2023.03.035. Epub 2023 Apr 7. PMID: 37031711.

Reddy CA, et al. Achalasia is Strongly Associated With Eosinophilic Esophagitis and Other Allergic Disorders. Clin Gastroenterol Hepatol. 2024 Jan;22(1):34-41.e2. doi: 10.1016/j.cgh.2023.06.013. Epub 2023 Jun 28. PMID: 37391057; PMCID: PMC10753026.

Thiruvengadam NR, et al. The Clinical Impact and Cost-Effectiveness of Surveillance of Incidentally Detected Gastric Intestinal Metaplasia: A Microsimulation Analysis. Clin Gastroenterol Hepatol. 2024 Jan;22(1):51-61. doi: 10.1016/j.cgh.2023.05.028. Epub 2023 Jun 9. Erratum in: Clin Gastroenterol Hepatol. 2024 Jan 19;: PMID: 37302442.

February 2024

Goodoory VC, et al. Systematic Review and Meta-analysis: Efficacy of Mesalamine in Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):243-251.e5. doi: 10.1016/j.cgh.2023.02.014. Epub 2023 Feb 27. PMID: 36858143.

Brenner DM, et al. Development and Current State of Digital Therapeutics for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2024 Feb;22(2):222-234. doi: 10.1016/j.cgh.2023.09.013. Epub 2023 Sep 22. PMID: 37743035.

Techniques and Innovations in Gastrointestinal Endoscopy

January 2024

Ramirez PR, et al. Gaps and Improvement Opportunities in Post-Colonoscopy Communication. Tech Innov Gastrointest Endosc. 2024 Jan;26(1):90-92. doi: 10.1016/j.tige.2023.10.001. Epub 2023 Oct 22.

Gonzaga ER, et al. Gastric Peroral Endoscopic Myotomy (G-POEM) for the Management of Gastroparesis. Tech Innov Gastrointest Endosc. 2024 Jan; 26(1): 46-55. doi: 10.1016/j.tige.2023.09.002. Epub 2023 Oct 13.

Wang D, et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2024 Jan;26(1): 30-37. doi: 10.1016/j.tige.2023.10.003. Epub 2023 Nov 8.

Gastro Hep Advances

January 2024

Adeniran E, et al. Intense and Sustained Alcohol Consumption Associated With Acute Pancreatitis Warrants Early Intervention. Gastro Hep Advances. 2024 Jan;3(1):61-63. doi: 10.1016/j.gastha.2023.08.017. Epub 2023 Sep 2.

Alkhouri N, et al. A Novel Prescription Digital Therapeutic Option for the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease. Gastro Hep Advances. 2024 Jan;3(1): 9-16. doi: 10.1016/j.gastha.2023.08.019. Epub 2023 Oct 1.

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Artificial Intelligence in GI and Hepatology

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Dear colleagues,

Since our prior Perspectives piece on artificial intelligence (AI) in GI and Hepatology in 2022, the field has seen almost exponential growth. Expectations are high that AI will revolutionize our field and significantly improve patient care. But as the global discussion on AI has shown, there are real challenges with adoption, including issues with accuracy, reliability, and privacy.

In this issue, Dr. Nabil M. Mansour and Dr. Thomas R. McCarty explore the current and future impact of AI on gastroenterology, while Dr. Basile Njei and Yazan A. Al Ajlouni assess its role in hepatology. We hope these pieces will help your discussions in incorporating or researching AI for use in your own practices. We welcome your thoughts on this issue on X @AGA_GIHN.

Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.

Artificial Intelligence in Gastrointestinal Endoscopy

BY THOMAS R. MCCARTY, MD, MPH; NABIL M. MANSOUR, MD

The last few decades have seen an exponential increase and interest in the role of artificial intelligence (AI) and adoption of deep learning algorithms within healthcare and patient care services. The field of gastroenterology and endoscopy has similarly seen a tremendous uptake in acceptance and implementation of AI for a variety of gastrointestinal conditions. The spectrum of AI-based applications includes detection or diagnostic-based as well as therapeutic assistance tools. From the first US Food and Drug Administration (FDA)-approved device that uses machine learning to assist clinicians in detecting lesions during colonoscopy, to other more innovative machine learning techniques for small bowel, esophageal, and hepatobiliary conditions, AI has dramatically changed the landscape of gastrointestinal endoscopy.

Approved applications for colorectal cancer

In an attempt to improve colorectal cancer screening and outcomes related to screening and surveillance, efforts have been focused on procedural performance metrics, quality indicators, and tools to aid in lesion detection and improve quality of care. One such tool has been computer-aided detection (CADe), with early randomized controlled trial (RCT) data showing significantly increased adenoma detection rate (ADR) and adenomas per colonoscopy (APC).^1-3

Ultimately, this data led to FDA approval of the CADe system GI Genius (Medtronic, Dublin, Ireland) in 2021.⁴ Additional systems have since been FDA approved or 510(k) cleared including Endoscreener (Wision AI, Shanghai, China), SKOUT (Iterative Health, Cambridge, Massachusetts), MAGENTIQ-COLO (MAGENTIQ-EYE LTD, Haifa, Israel), and CAD EYE (Fujifilm, Tokyo), all of which have shown increased ADR and/or increased APC and/or reduced adenoma miss rates in randomized trials.⁵

Yet despite the promise of improved quality and subsequent translation to better patient outcomes, there has been a noticeable disconnect between RCT data and more real-world literature.⁶ In a recent study, no improvement was seen in ADR after implementation of a CADe system for colorectal cancer screening — including both higher and lower-ADR performers. Looking at change over time after implementation, CADe had no positive effect in any group over time, divergent from early RCT data. In a more recent multicenter, community-based RCT study, again CADe did not result in a statistically significant difference in the number of adenomas detected.⁷ The differences between some of these more recent “real-world” studies vs the majority of data from RCTs raise important questions regarding the potential of bias (due to unblinding) in prospective trials, as well as the role of the human-AI interaction.

Importantly for RCT data, both cohorts in these studies met adequate ADR benchmarks, though it remains unclear whether a truly increased ADR necessitates better patient outcomes — is higher always better? In addition, an important consideration with evaluating any AI/CADe system is that they often undergo frequent updates, each promising improved accuracy, sensitivity, and specificity. This is an interesting dilemma and raises questions about the enduring relevance of studies conducted using an outdated version of a CADe system.

Additional unanswered questions regarding an ideal ADR for implementation, preferred patient populations for screening (especially for younger individuals), and the role and adoption of computer-aided polyp diagnosis/characterization (CADx) within the United States remain. Furthermore, questions regarding procedural withdrawal time, impact on sessile serrated lesion detection, cost-effectiveness, and preferred adoption strategies have begun to be explored, though require more data to better define a best practice approach. Ultimately, answers to some of these unknowns may explain the discordant results and help guide future implementation measures.

Innovative applications for alternative gastrointestinal conditions

Given the fervor and excitement, as well as the outcomes associated with AI-based colorectal screening, it is not surprising these techniques have been expanded to other gastrointestinal conditions. At this time, all of these are fledgling, mostly single-center tools, not yet ready for widespread adoption. Nonetheless, these represent a potentially important step forward for difficult-to-manage gastrointestinal diseases.

Machine learning CADe systems have been developed to help identify early Barrett’s neoplasia, depth and invasion of gastric cancer, as well as lesion detection in small bowel video capsule endoscopy.^8-10 Endoscopic retrograde cholangiopancreatography (ERCP)-based applications for cholangiocarcinoma and indeterminate stricture diagnosis have also been studied.¹¹ Additional AI-based algorithms have been employed for complex procedures such as endoscopic submucosal dissection (ESD) or peroral endoscopic myotomy (POEM) to delineate vessels, better define tissue planes for dissection, and visualize landmark structures.^12,13 Furthermore, AI-based scope guidance/manipulation, bleeding detection, landmark identification, and lesion detection have the potential to revolutionize endoscopic training and education. The impact that generative AI can potentially have on clinical practice is also an exciting prospect that warrants further investigation.

Artificial intelligence adoption in clinical practice

Clinical practice with regard to AI and colorectal cancer screening largely mirrors the disconnect in the current literature, with “believers” and “non-believers” as well as innovators and early adopters alongside laggards. In our own academic practices, we continue to struggle with the adoption and standardized implementation of AI-based colorectal cancer CADe systems, despite the RCT data showing positive results. It is likely that AI uptake will follow the technology predictions of Amara’s Law — i.e., individuals tend to overestimate the short-term impact of new technologies while underestimating long-term effects. In the end, more widespread adoption in community practice and larger scale real-world clinical outcomes studies are likely to determine the true impact of these exciting technologies. For other, less established AI-based tools, more data are currently required.

Conclusions

Ultimately, AI-based algorithms are likely here to stay, with continued improvement and evolution to occur based on provider feedback and patient care needs. Current tools, while not all-encompassing, have the potential to dramatically change the landscape of endoscopic training, diagnostic evaluation, and therapeutic care. It is critically important that relevant stakeholders, both endoscopists and patients, be involved in future applications and design to improve efficiency and quality outcomes overall.

Dr. McCarty is based in the Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist Hospital. Dr. Mansour is based in the section of gastroenterology, Baylor College of Medicine, Houston. Dr. McCarty reports no conflicts of interest. Dr. Mansour reports having been a consultant for Iterative Health.

References

1. Repici A, et al. Efficacy of real-time computer-aided detection of colorectal neoplasia in a randomized trial. Gastroenterology. 2020 Aug. doi: 10.1053/j.gastro.2020.04.062.

2. Repici A, et al. Artificial intelligence and colonoscopy experience: Lessons from two randomised trials. Gut. Apr 2022. doi: 10.1136/gutjnl-2021-324471.

3. Wallace MB, et al. Impact of artificial intelligence on miss rate of colorectal neoplasia. Gastroenterology 2022 Jul. doi: 10.1053/j.gastro.2022.03.007.

4. United States Food and Drug Administration (FDA). GI Genius FDA Approval [April 9, 2021]. Accessed January 5, 2022. Available at: www.accessdata.fda.gov/cdrh_docs/pdf21/K211951.pdf.

5. Maas MHJ, et al. A computer-aided polyp detection system in screening and surveillance colonoscopy: An international, multicentre, randomised, tandem trial. Lancet Digit Health. 2024 Mar. doi: 10.1016/S2589-7500(23)00242-X.

6. Ladabaum U, et al. Computer-aided detection of polyps does not improve colonoscopist performance in a pragmatic implementation trial. Gastroenterology. 2023 Mar. doi: 10.1053/j.gastro.2022.12.004.

7. Wei MT, et al. Evaluation of computer-aided detection during colonoscopy in the community (AI-SEE): A multicenter randomized clinical trial. Am J Gastroenterol. 2023 Oct. doi: 10.14309/ajg.0000000000002239.

8. de Groof J, et al. The Argos project: The development of a computer-aided detection system to improve detection of Barrett’s neoplasia on white light endoscopy. United European Gastroenterol J. 2019 May. doi: 10.1177/2050640619837443.

9. Kanesaka T, et al. Computer-aided diagnosis for identifying and delineating early gastric cancers in magnifying narrow-band imaging. Gastrointest Endosc. 2018 May. doi: 10.1016/j.gie.2017.11.029.

10. Sahafi A, et al. Edge artificial intelligence wireless video capsule endoscopy. Sci Rep. 2022 Aug. doi: 10.1038/s41598-022-17502-7.

11. Njei B, et al. Artificial intelligence in endoscopic imaging for detection of malignant biliary strictures and cholangiocarcinoma: A systematic review. Ann Gastroenterol. 2023 Mar-Apr. doi: 10.20524/aog.2023.0779.

12. Ebigbo A, et al. Vessel and tissue recognition during third-space endoscopy using a deep learning algorithm. Gut. 2022 Dec. doi: 10.1136/gutjnl-2021-326470.

13. Cao J, et al. Intelligent surgical workflow recognition for endoscopic submucosal dissection with real-time animal study. Nat Commun. 2023 Oct. doi: 10.1038/s41467-023-42451-8.

The Promise and Challenges of AI in Hepatology

BY BASILE NJEI, MD, MPH, PHD; YAZAN A. AL-AJLOUNI, MPHIL

In the dynamic realm of medicine, artificial intelligence (AI) emerges as a transformative force, notably within hepatology. The discipline of hepatology, dedicated to liver and related organ diseases, is ripe for AI’s promise to revolutionize diagnostics and treatment, pushing toward a future of precision medicine. Yet, the path to fully realizing AI’s potential in hepatology is laced with data, ethical, and integration challenges.

The application of AI, particularly in histopathology, significantly enhances disease diagnosis and staging in hepatology. AI-driven approaches remedy traditional histopathological challenges, such as interpretative variability, providing more consistent and accurate disease analyses. This is especially evident in conditions like metabolic dysfunction-associated steatohepatitis (MASH) and hepatocellular carcinoma (HCC), where AI aids in identifying critical gene signatures, thereby refining therapy selection.

Similarly, deep learning (DL), a branch of AI, has attracted significant interest globally, particularly in image recognition. AI’s incorporation into medical imaging marks a significant advancement, enabling early detection of malignancies like HCC and improving diagnostics in steatotic liver disease through enhanced imaging analyses using convolutional neural networks (CNN). The abundance of imaging data alongside clinical outcomes has catalyzed AI’s integration into radiology, leading to the swift growth of radiomics as a novel domain in medical research.

AI has also been shown to identify nuanced alterations in electrocardiograms (EKGs) associated with liver conditions, potentially detecting the progression of liver diseases at an earlier stage than currently possible. By leveraging complex algorithms and machine learning, AI can analyze EKG patterns with a precision and depth unattainable through traditional manual interpretation. Given that liver diseases, such as cirrhosis or hepatitis, can induce subtle cardiac changes long before other clinical symptoms manifest, early detection through AI-enhanced EKG analysis could lead to timely interventions, potentially halting or reversing disease progression. This approach further enriches our understanding of the intricate interplay between liver function and cardiac health, highlighting the potential for AI to transform not just liver disease diagnostics but also to foster a more integrated approach to patient care.

Beyond diagnostics, the burgeoning field of generative AI introduces groundbreaking possibilities in treatment planning and patient education, particularly for chronic conditions like cirrhosis. Generative AI produces original content, including text, visuals, and music, by identifying and learning patterns from its training data. When it leverages large language models (LLMs), it entails training on vast collections of textual data and using AI models characterized by many parameters. A notable instance of generative AI employing LLMs is ChatGPT (General Pretrained Transformers). By simulating disease progression and treatment outcomes, generative AI can foster personalized treatment strategies and empower patients with knowledge about their health trajectories. Yet, realizing these potential demands requires overcoming data quality and interpretability challenges, and ensuring AI outputs are accessible and actionable for clinicians and patients.

Despite these advancements, leveraging AI in hepatology is not devoid of hurdles. The development and training of AI models require extensive and diverse datasets, raising concerns about data privacy and ethical use. Addressing these concerns is paramount for successfully integrating AI into clinical hepatology practice, necessitating transparent algorithmic processes and stringent ethical standards. Ethical considerations are central to AI’s integration into hepatology. Algorithmic biases, patient privacy, and the impact of AI-driven decisions underscore the need for cautious AI deployment. Developing transparent, understandable algorithms and establishing ethical guidelines for AI use are critical steps towards ethically leveraging AI in patient care.

In conclusion, AI’s integration into hepatology holds tremendous promise for advancing patient care through enhanced diagnostics, treatment planning, and patient education. Overcoming the associated challenges, including ethical concerns, data diversity, and algorithm interpretability, is crucial. As the hepatology community navigates this technological evolution, a balanced approach that marries technological advancements with ethical stewardship will be key to harnessing AI’s full potential, ensuring it serves the best interests of patients and propels the field of hepatology into the future.

We predict a trajectory of increased use and adoption of AI in hepatology. AI in hepatology is likely to meet the test of pervasiveness, improvement, and innovation. The adoption of AI in routine hepatology diagnosis and management will likely follow Amara’s law and the five stages of the hype cycle. We believe that we are still in the infant stages of adopting AI technology in hepatology, and this phase may last 5 years before there is a peak of inflated expectations. The trough of disillusionment and slopes of enlightenment may only be observed in the next decades.

Dr. Njei is based in the Section of Digestive Diseases, Yale School of Medicine, New Haven, Conn. Mr. Al-Ajlouni is a senior medical student at New York Medical College School of Medicine, Valhalla, N.Y. They have no conflicts of interest to declare.

Sources

Taylor-Weiner A, et al. A Machine Learning Approach Enables Quantitative Measurement of Liver Histology and Disease Monitoring in NASH. Hepatology. 2021 Jul. doi: 10.1002/hep.31750.

Zeng Q, et al. Artificial intelligence predicts immune and inflammatory gene signatures directly from hepatocellular carcinoma histology. J Hepatol. 2022 Jul. doi: 10.1016/j.jhep.2022.01.018.

Ahn JC, et al. Development of the AI-Cirrhosis-ECG Score: An Electrocardiogram-Based Deep Learning Model in Cirrhosis. Am J Gastroenterol. 2022 Mar. doi: 10.14309/ajg.0000000000001617.

Nduma BN, et al. The Application of Artificial Intelligence (AI)-Based Ultrasound for the Diagnosis of Fatty Liver Disease: A Systematic Review. Cureus. 2023 Dec 15. doi: 10.7759/cureus.50601.

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All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Dear colleagues,Since our prior Perspectives piece on artificial intelligence (AI) in GI and Hepatology in 2022, the field has seen almost exponential growth. 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Mansour</description> <description role="drol:credit">Baylor College of Medicine</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012818.jpg</altRep> <description role="drol:caption">Dr. Basile Njei</description> <description role="drol:credit">Yale School of Medicine</description> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012817.jpg</altRep> <description role="drol:caption">Yazan A. Al-Ajlouni</description> <description role="drol:credit">New York Medical College</description> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Artificial Intelligence in GI and Hepatology</title> <deck/> </itemMeta> <itemContent> Dear colleagues, Since <a href="https://gastro.org/news/innovation-in-gi-whats-the-next-big-thing/">our prior Perspectives piece</a> on artificial intelligence (AI) in GI and Hepatology in 2022, the field has seen almost exponential growth. Expectations are high that AI will revolutionize our field and significantly improve patient care. But as the global discussion on AI has shown, there are real challenges with adoption, including issues with accuracy, reliability, and privacy. In this issue, Dr. Nabil M. Mansour and Dr. Thomas R. McCarty explore the current and future impact of AI on gastroenterology, while Dr. Basile Njei and Yazan A. Al Ajlouni assess its role in hepatology. We hope these pieces will help your discussions in incorporating or researching AI for use in your own practices. We welcome your thoughts on this issue on X <a href="https://twitter.com/AGA_GIHN">@AGA_GIHN</a>. Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News. <h2>Artificial Intelligence in Gastrointestinal Endoscopy</h2> BY THOMAS R. MCCARTY, MD, MPH; NABIL M. MANSOUR, MD The last few decades have seen an exponential increase and interest in the role of artificial intelligence (AI) and adoption of deep learning algorithms within healthcare and patient care services. The field of gastroenterology and endoscopy has similarly seen a tremendous uptake in acceptance and implementation of AI for a variety of gastrointestinal conditions. The spectrum of AI-based applications includes detection or diagnostic-based as well as therapeutic assistance tools. From the first US Food and Drug Administration (FDA)-approved device that uses machine learning to assist clinicians in detecting lesions during colonoscopy, to other more innovative machine learning techniques for small bowel, esophageal, and hepatobiliary conditions, AI has dramatically changed the landscape of gastrointestinal endoscopy.[[{"fid":"300209","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Dr. Nabil M. Mansour, McNair General GI Clinic at Baylor College of Medicine in Houston","field_file_image_credit[und][0][value]":"Baylor College of Medicine","field_file_image_caption[und][0][value]":"Dr. Nabil M. Mansour"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]] Approved applications for colorectal cancer In an attempt to improve colorectal cancer screening and outcomes related to screening and surveillance, efforts have been focused on procedural performance metrics, quality indicators, and tools to aid in lesion detection and improve quality of care. One such tool has been computer-aided detection (CADe), with early randomized controlled trial (RCT) data showing significantly increased adenoma detection rate (ADR) and adenomas per colonoscopy (APC).1-3 Ultimately, this data led to FDA approval of the CADe system GI Genius (Medtronic, Dublin, Ireland) in 2021.4 Additional systems have since been FDA approved or 510(k) cleared including Endoscreener (Wision AI, Shanghai, China), SKOUT (Iterative Health, Cambridge, Massachusetts), MAGENTIQ-COLO (MAGENTIQ-EYE LTD, Haifa, Israel), and CAD EYE (Fujifilm, Tokyo), all of which have shown increased ADR and/or increased APC and/or reduced adenoma miss rates in randomized trials.5 Yet despite the promise of improved quality and subsequent translation to better patient outcomes, there has been a noticeable disconnect between RCT data and more real-world literature.6 In a recent study, no improvement was seen in ADR after implementation of a CADe system for colorectal cancer screening — including both higher and lower-ADR performers. Looking at change over time after implementation, CADe had no positive effect in any group over time, divergent from early RCT data. In a more recent multicenter, community-based RCT study, again CADe did not result in a statistically significant difference in the number of adenomas detected.7 The differences between some of these more recent “real-world” studies vs the majority of data from RCTs raise important questions regarding the potential of bias (due to unblinding) in prospective trials, as well as the role of the human-AI interaction. Importantly for RCT data, both cohorts in these studies met adequate ADR benchmarks, though it remains unclear whether a truly increased ADR necessitates better patient outcomes — is higher always better? In addition, an important consideration with evaluating any AI/CADe system is that they often undergo frequent updates, each promising improved accuracy, sensitivity, and specificity. This is an interesting dilemma and raises questions about the enduring relevance of studies conducted using an outdated version of a CADe system. Additional unanswered questions regarding an ideal ADR for implementation, preferred patient populations for screening (especially for younger individuals), and the role and adoption of computer-aided polyp diagnosis/characterization (CADx) within the United States remain. Furthermore, questions regarding procedural withdrawal time, impact on sessile serrated lesion detection, cost-effectiveness, and preferred adoption strategies have begun to be explored, though require more data to better define a best practice approach. Ultimately, answers to some of these unknowns may explain the discordant results and help guide future implementation measures. Innovative applications for alternative gastrointestinal conditions Given the fervor and excitement, as well as the outcomes associated with AI-based colorectal screening, it is not surprising these techniques have been expanded to other gastrointestinal conditions. At this time, all of these are fledgling, mostly single-center tools, not yet ready for widespread adoption. Nonetheless, these represent a potentially important step forward for difficult-to-manage gastrointestinal diseases. Machine learning CADe systems have been developed to help identify early Barrett’s neoplasia, depth and invasion of gastric cancer, as well as lesion detection in small bowel video capsule endoscopy.8-10 Endoscopic retrograde cholangiopancreatography (ERCP)-based applications for cholangiocarcinoma and indeterminate stricture diagnosis have also been studied.11 Additional AI-based algorithms have been employed for complex procedures such as endoscopic submucosal dissection (ESD) or peroral endoscopic myotomy (POEM) to delineate vessels, better define tissue planes for dissection, and visualize landmark structures.12,13 Furthermore, AI-based scope guidance/manipulation, bleeding detection, landmark identification, and lesion detection have the potential to revolutionize endoscopic training and education. The impact that generative AI can potentially have on clinical practice is also an exciting prospect that warrants further investigation. Artificial intelligence adoption in clinical practice Clinical practice with regard to AI and colorectal cancer screening largely mirrors the disconnect in the current literature, with “believers” and “non-believers” as well as innovators and early adopters alongside laggards. In our own academic practices, we continue to struggle with the adoption and standardized implementation of AI-based colorectal cancer CADe systems, despite the RCT data showing positive results. It is likely that AI uptake will follow the technology predictions of Amara’s Law — i.e., individuals tend to overestimate the short-term impact of new technologies while underestimating long-term effects. In the end, more widespread adoption in community practice and larger scale real-world clinical outcomes studies are likely to determine the true impact of these exciting technologies. For other, less established AI-based tools, more data are currently required. Conclusions Ultimately, AI-based algorithms are likely here to stay, with continued improvement and evolution to occur based on provider feedback and patient care needs. Current tools, while not all-encompassing, have the potential to dramatically change the landscape of endoscopic training, diagnostic evaluation, and therapeutic care. It is critically important that relevant stakeholders, both endoscopists and patients, be involved in future applications and design to improve efficiency and quality outcomes overall. Dr. McCarty is based in the Lynda K. and David M. Underwood Center for Digestive Disorders, Houston Methodist Hospital. Dr. Mansour is based in the section of gastroenterology, Baylor College of Medicine, Houston. Dr. McCarty reports no conflicts of interest. Dr. Mansour reports having been a consultant for Iterative Health. <h2>References</h2> 1. Repici A, et al. Efficacy of real-time computer-aided detection of colorectal neoplasia in a randomized trial. Gastroenterology. 2020 Aug. doi: <a href="https://doi.org/10.1053/j.gastro.2020.04.062">10.1053/j.gastro.2020.04.062</a>. 2. Repici A, et al. Artificial intelligence and colonoscopy experience: Lessons from two randomised trials. Gut. Apr 2022. doi: <a href="https://gut.bmj.com/content/71/4/757">10.1136/gutjnl-2021-324471</a>. 3. Wallace MB, et al. Impact of artificial intelligence on miss rate of colorectal neoplasia. Gastroenterology 2022 Jul. doi: <a href="https://doi.org/10.1053/j.gastro.2022.03.007">10.1053/j.gastro.2022.03.007</a>. 4. United States Food and Drug Administration (FDA). GI Genius FDA Approval [April 9, 2021]. Accessed January 5, 2022. Available at: <a href="https://www.accessdata.fda.gov/cdrh_docs/pdf21/K211951.pdf">www.accessdata.fda.gov/cdrh_docs/pdf21/K211951.pdf</a>. 5. Maas MHJ, et al. A computer-aided polyp detection system in screening and surveillance colonoscopy: An international, multicentre, randomised, tandem trial. Lancet Digit Health. 2024 Mar. doi: <a href="https://www.thelancet.com/journals/landig/article/PIIS2589-7500(23)00242-X/fulltext">10.1016/S2589-7500(23)00242-X</a>. 6. Ladabaum U, et al. Computer-aided detection of polyps does not improve colonoscopist performance in a pragmatic implementation trial. Gastroenterology. 2023 Mar. doi: <a href="https://doi.org/10.1053/j.gastro.2022.12.004">10.1053/j.gastro.2022.12.004</a>. 7. Wei MT, et al. Evaluation of computer-aided detection during colonoscopy in the community (AI-SEE): A multicenter randomized clinical trial. Am J Gastroenterol. 2023 Oct. doi: <a href="https://journals.lww.com/ajg/abstract/2023/10000/evaluation_of_computer_aided_detection_during.28.aspx">10.14309/ajg.0000000000002239</a>. 8. de Groof J, et al. The Argos project: The development of a computer-aided detection system to improve detection of Barrett’s neoplasia on white light endoscopy. United European Gastroenterol J. 2019 May. doi: <a href="https://onlinelibrary.wiley.com/doi/10.1177/2050640619837443">10.1177/2050640619837443</a>. 9. Kanesaka T, et al. Computer-aided diagnosis for identifying and delineating early gastric cancers in magnifying narrow-band imaging. Gastrointest Endosc. 2018 May. doi: <a href="https://doi.org/10.1016/j.gie.2017.11.029">10.1016/j.gie.2017.11.029</a>. 10. Sahafi A, et al. Edge artificial intelligence wireless video capsule endoscopy. Sci Rep. 2022 Aug. doi: <a href="https://www.nature.com/articles/s41598-022-17502-7">10.1038/s41598-022-17502-7</a>. 11. Njei B, et al. Artificial intelligence in endoscopic imaging for detection of malignant biliary strictures and cholangiocarcinoma: A systematic review. Ann Gastroenterol. 2023 Mar-Apr. doi: <a href="https://doi.org/10.20524/aog.2023.0779">10.20524/aog.2023.0779</a>. 12. Ebigbo A, et al. Vessel and tissue recognition during third-space endoscopy using a deep learning algorithm. Gut. 2022 Dec. doi: <a href="https://gut.bmj.com/content/71/12/2388">10.1136/gutjnl-2021-326470</a>. 13. Cao J, et al. Intelligent surgical workflow recognition for endoscopic submucosal dissection with real-time animal study. Nat Commun. 2023 Oct. doi: <a href="https://www.nature.com/articles/s41467-023-42451-8">10.1038/s41467-023-42451-8</a>. <h2>The Promise and Challenges of AI in Hepatology</h2> BY BASILE NJEI, MD, MPH, PHD; YAZAN A. AL-AJLOUNI, MPHIL In the dynamic realm of medicine, artificial intelligence (AI) emerges as a transformative force, notably within hepatology. The discipline of hepatology, dedicated to liver and related organ diseases, is ripe for AI’s promise to revolutionize diagnostics and treatment, pushing toward a future of precision medicine. Yet, the path to fully realizing AI’s potential in hepatology is laced with data, ethical, and integration challenges. The application of AI, particularly in histopathology, significantly enhances disease diagnosis and staging in hepatology. AI-driven approaches remedy traditional histopathological challenges, such as interpretative variability, providing more consistent and accurate disease analyses. This is especially evident in conditions like metabolic dysfunction-associated steatohepatitis (MASH) and hepatocellular carcinoma (HCC), where AI aids in identifying critical gene signatures, thereby refining therapy selection. [[{"fid":"301101","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Dr. Basile Njei, Section of Digestive Diseases, Yale School of Medicine, New Haven, Conn.","field_file_image_credit[und][0][value]":"Yale School of Medicine","field_file_image_caption[und][0][value]":"Dr. Basile Njei"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]Similarly, deep learning (DL), a branch of AI, has attracted significant interest globally, particularly in image recognition. AI’s incorporation into medical imaging marks a significant advancement, enabling early detection of malignancies like HCC and improving diagnostics in steatotic liver disease through enhanced imaging analyses using convolutional neural networks (CNN). The abundance of imaging data alongside clinical outcomes has catalyzed AI’s integration into radiology, leading to the swift growth of radiomics as a novel domain in medical research. AI has also been shown to identify nuanced alterations in electrocardiograms (EKGs) associated with liver conditions, potentially detecting the progression of liver diseases at an earlier stage than currently possible. By leveraging complex algorithms and machine learning, AI can analyze EKG patterns with a precision and depth unattainable through traditional manual interpretation. Given that liver diseases, such as cirrhosis or hepatitis, can induce subtle cardiac changes long before other clinical symptoms manifest, early detection through AI-enhanced EKG analysis could lead to timely interventions, potentially halting or reversing disease progression. This approach further enriches our understanding of the intricate interplay between liver function and cardiac health, highlighting the potential for AI to transform not just liver disease diagnostics but also to foster a more integrated approach to patient care. [[{"fid":"301100","view_mode":"medstat_image_flush_right","fields":{"format":"medstat_image_flush_right","field_file_image_alt_text[und][0][value]":"Yazan A. Al-Ajlouni, senior medical student at New York Medical College School of Medicine, Valhalla, N.Y.","field_file_image_credit[und][0][value]":"New York Medical College","field_file_image_caption[und][0][value]":"Yazan A. Al-Ajlouni"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_right"}}]]Beyond diagnostics, the burgeoning field of generative AI introduces groundbreaking possibilities in treatment planning and patient education, particularly for chronic conditions like cirrhosis. Generative AI produces original content, including text, visuals, and music, by identifying and learning patterns from its training data. When it leverages large language models (LLMs), it entails training on vast collections of textual data and using AI models characterized by many parameters. A notable instance of generative AI employing LLMs is ChatGPT (General Pretrained Transformers). By simulating disease progression and treatment outcomes, generative AI can foster personalized treatment strategies and empower patients with knowledge about their health trajectories. Yet, realizing these potential demands requires overcoming data quality and interpretability challenges, and ensuring AI outputs are accessible and actionable for clinicians and patients. Despite these advancements, leveraging AI in hepatology is not devoid of hurdles. The development and training of AI models require extensive and diverse datasets, raising concerns about data privacy and ethical use. Addressing these concerns is paramount for successfully integrating AI into clinical hepatology practice, necessitating transparent algorithmic processes and stringent ethical standards. Ethical considerations are central to AI’s integration into hepatology. Algorithmic biases, patient privacy, and the impact of AI-driven decisions underscore the need for cautious AI deployment. Developing transparent, understandable algorithms and establishing ethical guidelines for AI use are critical steps towards ethically leveraging AI in patient care. In conclusion, AI’s integration into hepatology holds tremendous promise for advancing patient care through enhanced diagnostics, treatment planning, and patient education. Overcoming the associated challenges, including ethical concerns, data diversity, and algorithm interpretability, is crucial. As the hepatology community navigates this technological evolution, a balanced approach that marries technological advancements with ethical stewardship will be key to harnessing AI’s full potential, ensuring it serves the best interests of patients and propels the field of hepatology into the future. We predict a trajectory of increased use and adoption of AI in hepatology. AI in hepatology is likely to meet the test of pervasiveness, improvement, and innovation. The adoption of AI in routine hepatology diagnosis and management will likely follow Amara’s law and the five stages of the hype cycle. We believe that we are still in the infant stages of adopting AI technology in hepatology, and this phase may last 5 years before there is a peak of inflated expectations. The trough of disillusionment and slopes of enlightenment may only be observed in the next decades. Dr. Njei is based in the Section of Digestive Diseases, Yale School of Medicine, New Haven, Conn. Mr. Al-Ajlouni is a senior medical student at New York Medical College School of Medicine, Valhalla, N.Y. They have no conflicts of interest to declare. <h2>Sources</h2> Taylor-Weiner A, et al. A Machine Learning Approach Enables Quantitative Measurement of Liver Histology and Disease Monitoring in NASH. Hepatology. 2021 Jul. doi: <a href="https://journals.lww.com/hep/toc/2021/07000">10.1002/hep.31750</a>. Zeng Q, et al. Artificial intelligence predicts immune and inflammatory gene signatures directly from hepatocellular carcinoma histology. J Hepatol. 2022 Jul. doi: <a href="https://doi.org/10.1016/j.jhep.2022.01.018">10.1016/j.jhep.2022.01.018</a>. Ahn JC, et al. Development of the AI-Cirrhosis-ECG Score: An Electrocardiogram-Based Deep Learning Model in Cirrhosis. Am J Gastroenterol. 2022 Mar. doi: <a href="https://journals.lww.com/ajg/toc/2022/03000">10.14309/ajg.0000000000001617</a>. Nduma BN, et al. The Application of Artificial Intelligence (AI)-Based Ultrasound for the Diagnosis of Fatty Liver Disease: A Systematic Review. Cureus. 2023 Dec 15. doi: <a href="https://www.cureus.com/articles/187909-the-application-of-artificial-intelligence-ai-based-ultrasound-for-the-diagnosis-of-fatty-liver-disease-a-systematic-review#!/">10.7759/cureus.50601</a>. </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>

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AGA Guides Usage of GLP-1 Receptor Agonists Before Endoscopy

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The American Gastroenterological Association (AGA) has issued a rapid clinical practice update on the use of glucagon-like peptide 1 (GLP-1) receptor agonists prior to endoscopy.

The update was partly prompted by consensus-based perioperative guidance issued by the American Society of Anesthesiologists in June 2023, which advises withholding GLP-1 receptor agonists before endoscopy. This recommendation has caused some anesthesia providers to cancel or postpone endoscopic procedures, or even elect general endotracheal intubation over standard sedation.

“Many facilities and medical centers are now struggling to revise preprocedural protocols for patients taking this class of medications despite the lack of high-level evidence regarding how to proceed,” the panelists wrote in Clinical Gastroenterology and Hepatology. “Important questions include whether these preprocedural changes are necessary, if they truly mitigate periprocedural aspiration, or if the delays instituted by following this guidance might further compound the major problem currently faced nationwide: that of large numbers of patients awaiting endoscopic procedures because of delays from the COVID-19 pandemic, reduction in the recommended age threshold to start colorectal cancer screening in 2018, and workforce challenges.”

The rapid clinical practice update, commissioned and approved by the AGA, includes background on the relationship between GLP-1 receptor agonists and endoscopic procedures, followed by clinical strategies for patients taking these medications.

Lead panelist Jana G. Al Hashash, MD, MSc, AGAF, of Mayo Clinic, Jacksonville, Florida, and colleagues began by noting that GLP-1 receptor agonists have been associated with increased gastric residue in patients with diabetes, and among nondiabetic patients, increased gastric retention of solids but not liquids. Delayed gastric emptying and increased residual gastric contents may be more common among patients on GLP-1 agonists who have vomiting, nausea, dyspepsia, or abdominal bloating, they added.

The above findings “imply an increased risk of aspiration in patients receiving GLP-1 receptor agonist medications who present for procedures that require sedation,” the panelists wrote, but more data is needed to support this hypothesis.

Yet the implications for endoscopic risk are still unclear.

Residual liquid in the stomach, at least, is “less of an issue,” according to the update, since “it is easily removed during an esophagogastroduodenoscopy, and this is the first maneuver performed by endoscopists on entering the stomach.”

While residual solids in the stomach could theoretically increase risk of aspiration, other patients with gastroparesis, such as those taking opioids, are not routinely given “special dietary precautions or medication adjustments” prior to endoscopy, Dr. Al Hashash and colleagues wrote. Even patients with severe gastroparesis who are undergoing gastric peroral endoscopic myotomy (which depends upon an empty stomach), are only required to stop ingesting solid foods the day before the procedure, they noted.

“It is appropriate that the ASA’s perioperative suggestions for patients on GLP-1 [receptor agonists] are labeled ‘consensus-based guidance on perioperative management,’ because there is clearly insufﬁcient published evidence for a robust systematic review and guideline,” they wrote. “As such, the ASA’s suggestions are expert opinions, which may inform but should not replace clinical judgment.”

The panelists therefore called for an individualized approach when managing GLP-1 receptor agonists prior to endoscopy, particularly in patients with diabetes, for whom withholding these medications “might provide more risk than benefit.”

Withholding GLP-1 receptor agonists may be safe and reasonable for patients taking them solely for weight loss, but “this should not be considered mandatory or evidence-based,” as it remains unclear whether withholding one dose is enough to restore normal gastric motility.

“Generally, in patients on GLP-1 receptor agonists who have followed standard perioperative procedures (typically an 8-hour solid-food fast and a 2-hour liquid fast) and who do not have symptoms of nausea, vomiting, dyspepsia, or abdominal distention, we advise proceeding with upper and/or lower endoscopy,” the panelists concluded.

The rapid clinical practice update was commissioned and approved by the AGA. The update panelists disclosed relationships with Apollo Endosurgery, Medtronic, Boston Scientific, and others.

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The Gamer Who Became a GI Hospitalist and Dedicated Endoscopist

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Reflecting on his career in gastroenterology, Andy Tau, MD, (@DrBloodandGuts on X) claims the discipline chose him, in many ways.

“I love gaming, which my mom said would never pay off. Then one day she nearly died from a peptic ulcer, and endoscopy saved her,” said Dr. Tau, a GI hospitalist who practices with Austin Gastroenterology in Austin, Texas. One of his specialties is endoscopic hemostasis.

Endoscopy functions similarly to a game because the interface between the operator and the patient is a controller and a video screen, he explained. “Movements in my hands translate directly onto the screen. Obviously, endoscopy is serious business, but the tactile feel was very familiar and satisfying to me.”

Advocating for the GI hospitalist and the versatile role they play in hospital medicine, is another passion of his. “The dedicated GI hospitalist indirectly improves the efficiency of an outpatient practice, while directly improving inpatient outcomes, collegiality, and even one’s own skills as an endoscopist,” Dr. Tau wrote in an opinion piece in GI & Hepatology News .

He expounded more on this topic and others in an interview, recalling what he learned from one mentor about maintaining a sense of humor at the bedside.

Q: You’ve said that GI hospitalists are the future of patient care. Can you explain why you feel this way?

Dr. Tau: From a quality perspective, even though it’s hard to put into one word, the care of acute GI pathology and endoscopy can be seen as a specialty in and of itself. These skills include hemostasis, enteral access, percutaneous endoscopic gastrostomy (PEG), balloon-assisted enteroscopy, luminal stenting, advanced tissue closure, and endoscopic retrograde cholangiopancreatography. The greater availability of a GI hospitalist, as opposed to an outpatient GI doctor rounding at the ends of days, likely shortens admissions and improves the logistics of scheduling inpatient cases.

From a financial perspective, the landscape of GI practice is changing because of GI physician shortages relative to increased demand for outpatient procedures. Namely, the outpatient gastroenterologists simply have too much on their plate and inefficiencies abound when they have to juggle inpatient and outpatient work. Thus, two tracks are forming, especially in large busy hospitals. This is the same evolution of the pure outpatient internist and inpatient internist 20 years ago.

Q: What attributes does a GI hospitalist bring to the table?

Dr. Tau: A GI hospitalist is one who can multitask through interruptions, manage end-of-life issues, craves therapeutic endoscopy (even if that’s hemostasis), and can keep more erratic hours based on the number of consults that come in. She/he tends to want immediate gratification and doesn’t mind the lack of continuity of care. Lastly, the GI hospitalist has to be brave and yet careful as the patients are sicker and thus complications may be higher and certainly less well tolerated.

Q: Are there enough of them going into practice right now?

Dr. Tau: Not really! The demand seems to outstrip supply based on what I see. There is a definite financial lure as the market rate for them rises (because more GIs are leaving the hospital for pure outpatient practice), but burnout can be an issue. Interestingly, fellows are typically highly trained and familiar with inpatient work, but once in practice, most choose the outpatient track. I think it’s a combination of work-life balance, inefficiency of inpatient endoscopy, and perhaps the strain of daily, erratic consultation.

Q: You received the 2021 Travis County Medical Society (TCMS) Young Physician of the Year. What achievements led to this honor?

Dr. Tau: I am not sure I am deserving of that award, but I think it was related to personal risk and some long hours as a GI hospitalist during the COVID pandemic. I may have the unfortunate distinction of performing more procedures on COVID patients than any other physician in the city. My hospital was the largest COVID-designated site in the city. There were countless PEG tubes in COVID survivors and a lot of bleeders for some reason. A critical care physician on the front lines and health director of the city of Austin received Physician of the Year, deservedly.

Q: What teacher or mentor had the greatest impact on you?

Dr. Tau: David Y. Graham, MD, MACG, got me into GI as a medical student and taught me to never tolerate any loose ends when it came to patient care as a resident. He trained me at every level — from medical school, residency, and through my fellowship. His advice is often delivered sly and dry, but his humor-laden truths continue to ring true throughout my life. One story: my whole family tested positive for Helicobacter pylori after my mother survived peptic ulcer hemorrhage. I was the only one who tested negative! I asked Dr Graham about it and he quipped, “You’re lucky! It’s because your mother didn’t love (and kiss) you as much!”

Even to this moment I laugh about that. I share that with my patients when they ask about how they contracted H. pylori.

Lightning Round

Favorite junk food?

McDonalds fries

Favorite movie genre?

Psychological thriller

Cat person or dog person?

Dog

What was your favorite Halloween costume?

Ninja turtle

Favorite sport:

Football (played in college)

Introvert or extrovert?

Extrovert unless sleep deprived.

Favorite holiday:

Thanksgiving

The book you read over and over:

Swiss Family Robinson

Favorite travel destination:

Hawaii

Optimist or pessimist?

A happy pessimist.

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Reflecting on his career in gastroenterology, Andy Tau, MD, (@DrBloodandGuts on X) claims the discipline chose him, in many ways.

Q: You’ve said that GI hospitalists are the future of patient care. Can you explain why you feel this way?

Q: What attributes does a GI hospitalist bring to the table?

Q: Are there enough of them going into practice right now?

Q: You received the 2021 Travis County Medical Society (TCMS) Young Physician of the Year. What achievements led to this honor?

Q: What teacher or mentor had the greatest impact on you?

Even to this moment I laugh about that. I share that with my patients when they ask about how they contracted H. pylori.

Lightning Round

Favorite junk food?

McDonalds fries

Favorite movie genre?

Psychological thriller

Cat person or dog person?

Dog

What was your favorite Halloween costume?

Ninja turtle

Favorite sport:

Football (played in college)

Introvert or extrovert?

Extrovert unless sleep deprived.

Favorite holiday:

Thanksgiving

The book you read over and over:

Swiss Family Robinson

Favorite travel destination:

Hawaii

Optimist or pessimist?

A happy pessimist.

Reflecting on his career in gastroenterology, Andy Tau, MD, (@DrBloodandGuts on X) claims the discipline chose him, in many ways.

Q: You’ve said that GI hospitalists are the future of patient care. Can you explain why you feel this way?

Q: What attributes does a GI hospitalist bring to the table?

Q: Are there enough of them going into practice right now?

Q: You received the 2021 Travis County Medical Society (TCMS) Young Physician of the Year. What achievements led to this honor?

Q: What teacher or mentor had the greatest impact on you?

Even to this moment I laugh about that. I share that with my patients when they ask about how they contracted H. pylori.

Lightning Round

Favorite junk food?

McDonalds fries

Favorite movie genre?

Psychological thriller

Cat person or dog person?

Dog

What was your favorite Halloween costume?

Ninja turtle

Favorite sport:

Football (played in college)

Introvert or extrovert?

Extrovert unless sleep deprived.

Favorite holiday:

Thanksgiving

The book you read over and over:

Swiss Family Robinson

Favorite travel destination:

Hawaii

Optimist or pessimist?

A happy pessimist.

Publications

GI and Hepatology News

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Endoscopy

Endoscopy, Pancreas, & Biliary Tract

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Dear Friends,

After 6 months in my first faculty position, I have come to appreciate the term “multidisciplinary approach” more than ever. Not only does this facilitate optimal patient care, but I have personally learned so much from experts in other fields. This theme resonates across this issue of The New Gastroenterologist, from treating complex gallbladder disease, to caring for sexual and gender minorities, and collaborating with the tech industry to advance patient care.

Our “In Focus” feature, written by Dr. Andrew Gilman and Dr. Todd Baron, is on endoscopic management of gallbladder disease. They review endoscopic treatment options in patients with benign gallbladder disease, with emphasis on working with surgical and interventional radiology colleagues, as well as relaying endoscopic tips and techniques to achieve success in these complicated procedures.

In the “Short Clinical Reviews” section, Dr. David Chiang and Dr. Victor Chedid highlight the gaps in research and clinical care and competency for sexual and gender minorities, particularly in patients with inflammatory bowel disease. They describe the creation of the Pride in IBD clinic at Mayo Clinic in Rochester, Minn., that creates a culturally sensitive space to care for this community.

As trainees transition to early faculty, becoming a mentor is a new role that can be very rewarding and daunting at the same time. Dr. Anna Lok, recipient of the AGA’s Distinguished Mentor Award, and Dr. Vincent Chen share invaluable experiences and advice on being a mentor from senior and early-career perspectives, respectively. Similarly in the transition to early faculty, Erin Anderson, CPA, answers five common financial questions that arise to better understand and manage a significant increase in salary.

Lastly, Dr. Shifa Umar describes her unique experience as part of the AGA’s annual Tech Summit Fellows Program, a cross-section of medicine, technology, and innovation.

If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu), or Jillian Schweitzer (jschweitzer@gastro.org), managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The concept of the clinicopathologic conference (CPC) was introduced by Dr. Walter B. Cannon as a medical student at Harvard Medical School.

Yours truly,

Judy A. Trieu, MD, MPH

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Interventional Endoscopy, Division of Gastroenterology

Washington University in St. Louis

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Endoscopic Management of Benign Gallbladder Disease

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Andrew J. Gilman

Todd H. Baron

Introduction

The treatment of benign gallbladder disease has changed substantially in the past decade, but this represents only a snapshot in the evolutionary history of the management of this organ. What began as a problem managed exclusively by open cholecystectomy (CCY) transitioned into a race toward minimally invasive approaches in the 1980s, with advances from gastroenterology, surgery, and radiology.

The opening strides were made in 1980 with the first description of percutaneous cholecystostomy (PC) by Dr. R.W. Radder.¹ Shortly thereafter, in 1984, Dr. Richard Kozarek first reported the feasibility of selective cystic duct cannulation during endoscopic retrograde cholangiopancreatography (ERCP).² Subsequent stenting for the treatment of acute cholecystitis (endoscopic transpapillary gallbladder drainage, ET-GBD) was then reported by Tamada et. al. in 1991.³ Not to be outdone, the first laparoscopic cholecystectomy (LC) was completed by Dr. Med Erich Mühe of Germany in 1985.⁴ More recently, with the expansion of interventional endoscopic ultrasound (EUS), the first transmural EUS-guided gallbladder drainage (EUS-GBD) was described by Dr. Baron and Dr. Topazian in 2007.⁵

The subsequent advent of lumen apposing metal stents (LAMS) has cemented EUS-GBD in the toolbox of treatment for benign gallbladder disease. Results of a recent prospective multicenter trial, with a Food and Drug Administration–approved protocol and investigational device exemption, have been published, opening the door for the expansion of FDA approved indications for this device.⁶

Benign gallbladder disease encompasses both polyps (benign and premalignant) and cholecystitis (acute/chronic, calculous/acalculous), in addition to others. The four management techniques (LC, PC, ET-GBD, and EUS-GBD) have filled integral niches in the management of these patients. Even gallbladder polyps have not been able to escape the reach of endoscopic approaches with the recent description of LAMS-assisted polypectomy as part of a gallbladder preserving strategy.^7,8 While EUS-GBD also has been used for biliary decompression in the presence of a patent cystic duct and absence of cholecystitis, this article will focus on ET-GBD and EUS-GBD for the primary treatment of cholecystitis or symptomatic cholelithiasis.⁹ Both of these techniques have gained wide recognition and/or guideline support for their use from the American Society for Gastrointestinal Endoscopy (ASGE) and the European Society of Gastrointestinal Endoscopy (ESGE).^10,11 In addition, there is now one FDA-approved stent device for treatment of acute cholecystitis in patients unfit for surgery.

Techniques & Tips

ET-GBD

During ERCP, after successful cannulation of the bile duct, attempted wire cannulation of the cystic duct is performed.

A cholangiogram, which clearly delineates the insertion of the cystic duct into the main bile duct, can enhance cannulation success. Rotatable fluoroscopy can facilitate identification.

After anatomy is clear, wire access is often best achieved using a sphincterotome or stone retrieval (occlusion) balloon.

The balloon, once inflated, can be pulled downward to establish traction on the main bile duct, which can straighten the approach.

After superficial wire engagement into the cystic duct, the accessory used can be slowly advanced into the cystic duct to stabilize the catheter and then navigate the valves of Heister to reach the gallbladder lumen.

Use of a sphincterotome, which directs toward the patient’s right (most often direction of cystic duct takeoff), is helpful. Angled guidewires are preferable. We often use a 0.035-inch, 260-cm angled hydrophilic wire (GLIDEWIRE; Terumo, Somerset, NJ) to overcome this challenging portion of ET-GBD.

If despite the above maneuvers the guidewire has failed to enter the cystic duct, cholangioscopy can be used to identify the orifice and/or stabilize deep wire cannulation. This is often cumbersome, time consuming, does not always produce success, and requires additional expertise.

If a stone is encountered that cannot be extracted or traversed by a guidewire, cholangioscopy with electrohydraulic lithotripsy can be pursued.
After the guidewire has entered the gallbladder, a 5 French or 7 French plastic double pigtail stent is placed. Typical lengths are 9-15 cm.

Some authors prefer to use two side-by-side plastic stents.¹² This has been shown retrospectively to enhance the long term clinical success of ET-GBD but with additional technical difficulty.

This stent can remain in place indefinitely and need not be exchanged, though it should be removed just prior to CCY if pursued. Alternatively, the surgeon can be alerted to its presence and, if comfortable, it can be removed intraoperatively.

EUS-GBD

Use of fluoroscopy is optional but can enhance technical success in selected situations.
Conversion, or internalization, of PC is reasonable and can enhance patient quality of life.¹³
If the gallbladder wall is not in close apposition to the duodenal (or gastric) wall, consider measuring the distance.

We preferentially use 10-mm diameter by 10-mm saddle length LAMS for EUS-GBD, unless the above distance warrants use of a 15-mm by 15-mm LAMS (AXIOS, Boston Scientific, Marlborough, MA). If the distance is greater than 15 mm, consider searching for an alternative site, using a traditional biliary fully covered self-expandable metal stent (FCSEMS) for longer length, or converting to ET-GBD. Smaller diameter (8 mm) with an 8-mm saddle length can be used as well. The optimal diameter is unknown and also dependent on whether transluminal endoscopic diagnosis or therapy is a consideration.

If there is difficulty locating the gallbladder, it may be decompressed or small (particularly if PC or a partial CCY has already been performed).

If a cholecystostomy tube is in place, instillation of sterile water via the tube can sometimes improve the target for LAMS placement, though caution should be made to not over-distend the gallbladder. ERCP with placement of a nasobiliary tube into the gallbladder can also serve this purpose and has been previously described.¹⁴

The gallbladder can be punctured with a 19-gauge FNA needle to instill sterile water and distend the gallbladder with the added benefit of being able to pass a guidewire, which may enhance procedural safety in difficult cases. However, success of this technique is contingent on fluid remaining within the gallbladder and not transiting out via the cystic duct. Expedient exchange of the FNA needle for the LAMS device may be necessary.

Attempt to confirm location within the duodenum prior to puncture, as gastric origins can pose unique ramifications (i.e. potential for partial gastric outlet obstruction, obstruction of LAMS with food debris, etc.).

It can be easy to mistake an unintentional pre-pyloric position for a position within the duodenum since the working channel is behind (proximal to) the echoprobe.

Turning off Doppler flow prior to advancement of the cautery enhanced LAMS can reduce obscurement of views on entry into the gallbladder. Lack of certainty about entry or misdeployment after presumed entry herald the most challenging aspect of EUS-GBD.

Utilization of a previously placed guidewire or advancement of one preloaded into the LAMS can aid in both enhancing confidence in location and assist with salvage maneuvers, if needed.

After successful deployment of the LAMS we routinely place a double pigtail plastic stent through it (typically 7 French by 4 cm) to maintain patency. This may also prevent bleeding from the LAMS flange abrading the wall of either lumen.
We routinely exchange the LAMS for two double pigtail plastic stents (typically 7 French by 4 cm) 4 weeks after initial placement especially when there is a more than modest residual stone burden (data in press). These plastic stents can remain in place indefinitely.

This exchange can be deferred if the patient is not expected to survive until the one-year anniversary of LAMS deployment. After one year the LAMS plastic covering may degrade and pose additional problems.¹⁵

LAMS Misdeployment Salvage Tips

Salvage techniques can vary from simple to complex.
If a wire is in place, it can be used to balloon or catheter dilate the tract and place a FCSEMS traversing the gallbladder and duodenal/gastric lumens. A similar approach can be used if the LAMS deployed on only one side (gallbladder or duodenum/stomach) and the other flange is within the peritoneum.
The most challenging scenario to salvage is if the LAMS is misdeployed or becomes dislodged and no wire is present. This is why the use of a guidewire, even if preloaded into the LAMS and placement is freehand, is essential for EUS-GBD. A potential technique is to balloon dilate the duodenal/gastric defect and drive the endoscope into the peritoneum to reconnect that lumen to the gallbladder defect or LAMS, depending on the site of misdeployment. Doing so requires a high degree of commitment and skill and should not be done casually.
If uncertainty remains or if misdeployment has occurred and salvage attempts have failed, consider closure of the duodenal/gastric defect and conversion to ET-GBD.

This may both treat the initial procedural indication and assist with what is essentially a large bile leak, which might also require percutaneous therapy for non-surgical management.

For endoscopists with limited experience at salvage techniques, it is reasonable for the threshold for conversion to be low, assuming experience with and confidence in ET-GBD is high.
If salvage is successful but ambiguity remains, consider obtaining a cholangiogram via the LAMS to confirm positioning and absence of leak.

Adverse Events

Both ET-GBD and EUS-GBD should be performed by an endoscopist comfortable with their techniques and the management of their adverse events (AEs). Rates for EUS-GBD AEs in patients at high risk for LC were reported in one international multicenter registry to be 15.3% with a 30-day mortality of 9.2%, with a significant predictor of AE being endoscopist experience less than 25 procedures.¹⁶ A meta-analysis also found an overall AE rate of 18.31%, with rates for perforation and stent related AEs (i.e. migration, occlusion, pneumoperitoneum) being 6.71% and 8.16%, respectively.¹⁷ For this reason, we recommend that patients with cholecystitis who are deemed to be poor surgical candidates be transferred to a tertiary referral center with expertise in these approaches. Rates of AEs for ET-GBD are similar to that for standard ERCP, with reported ranges of 5%-10.3%.¹⁰

Comparisons Between Techniques

The decision on which technique to utilize for endoscopic management of cholecystitis or symptomatic cholelithiasis depends first and foremost on the expertise and comfort level of the endoscopist. Given the additional training that an advanced endoscopist needs to perform EUS-GBD, combined with the perhaps slightly higher AE rate and permanency of endoscopic cholecystostomy, it is reasonable to proceed with a trial of ET-GBD if confidence is insufficient. However, ET-GBD can certainly be more technically challenging and less effective than EUS-GBD, with lower reported technical and clinical success rates (technical 85.3% vs 93.0%, clinical 95.2% vs 97.3%).¹⁸ Despite this, the rate of recurrence of cholecystitis is similar between ET-GBD and EUS-GBD (4.6% vs 4.2%).¹⁹ As stated above in the Techniques & Tips section, some authors utilize two plastic stents for ET-GBD for this purpose, though with increased technical difficulty. It is important to remember that these numbers, when paired with AE rates, represent the achievements of expert endoscopists.

Discussion with your surgery team is important when deciding modality. If the patient is felt to be a potential candidate for CCY, and EUS-GBD is not being used as a destination therapy, the surgeon may prefer ET-GBD. EUS-GBD may enhance the difficulty of CCY, though at least one study demonstrated that this was no different than PC with similar rates of conversion from LC to open CCY.²⁰ This conversation is most critical for patients who are potential liver transplant candidates. For patients where this is not a consideration there is some evidence to suggest equivalency between LC and EUS-GBD, though certainly EUS-GBD has not yet supplanted LC as the treatment of choice.²¹

While there may eventually be a shift towards EUS-GBD instead of LC in certain patient groups, what is clearer are the advantages of EUS-GBD over PC. One recent meta-analysis revealed that EUS-GBD has significantly favorable odds of overall adverse events (OR 0.43, 95% CI 0.18-1.00), shorter hospital stay (2.76 less days, 95% CI 0.31-5.20 less days), reinterventions (OR 0.15, 95% CI 0.02-0.98), and unplanned readmissions (OR 0.14, 95% CI 0.03-0.70) compared to PC.²² Beyond the data, though, are the emotional and psychological impacts an external drain can have on a patient.

Conclusion

When expertise is available, endoscopic treatment of benign gallbladder disease has a definite role but should be undertaken only by those with the experience and skill to safely do so. Decision to proceed, especially with EUS-GBD, should be accompanied by conversation and collaboration with surgical teams. If a patient is under consideration for PC instead of LC, it may be worthwhile to seek consultation with a local center with expertise in EUS-GBD or ET-GBD. The adoption of these techniques is part of the paradigm shift, seen broadly throughout medicine, towards minimally invasive interventions, particularly in advanced endoscopy.

Dr. Gilman (X @a_gilman) and Dr. Baron (X @EndoTx) are with the University of North Carolina, Chapel Hill, Division of Gastroenterology & Hepatology. Dr. Gilman has no relevant financial disclosures. Dr. Baron is a consultant and speaker for Ambu, Boston Scientific, Cook Endoscopy, Medtronic, Olympus America, and W.L. Gore.

References

1. Radder RW. Ultrasonically guided percutaneous catheter drainage for gallbladder empyema. Diagn Imaging. 1980;49:330-333.

2. Kozarek RA. Selective cannulation of the cystic duct at time of ERCP. J Clin Gastroenterol. 1984;6:37-40.

3. Tamada K et al. Efficacy of endoscopic retrograde cholecystoendoprosthesis (ERCCE) for cholecystitis. Endoscopy. 1991;23:2-3.

4. Reynolds W. The first laparoscopic cholecystectomy. JSLS. 2001;5:89-94.

5. Baron TH, Topazian MD. Endoscopic transduodenal drainage of the gallbladder: Implications for endoluminal treatment of gallbladder disease. Gastrointest Endosc. 2007 Apr;65(4):735-7. doi: 10.1016/j.gie.2006.07.041.

6. Irani SS et al. Endoscopic ultrasound-guided transluminal gallbladder drainage in patients with acute cholecystitis: A prospective multicenter trial. Ann Surg. 2023 Sep 1;278(3):e556-e562. doi: 10.1097/SLA.0000000000005784.

7. Shen Y et al. Endoscopic ultrasound-guided cholecystostomy for resection of gallbladder polyps with lumen-apposing metal stent. Medicine (Baltimore). 2020 Oct 23;99(43):e22903. doi: 10.1097/MD.0000000000022903.

8. Pang H et al. Endoscopic ultrasound-guided gallbladder endoscopic mucosal resection: A pilot porcine study. Minim Invasive Ther Allied Technol. 2023 Feb;32(1):24-32. doi: 10.1080/13645706.2022.2153228.

9. Imai H et al. EUS-guided gallbladder drainage for rescue treatment of malignant distal biliary obstruction after unsuccessful ERCP. Gastrointest Endosc. 2016 Jul;84(1):147-51. doi: 10.1016/j.gie.2015.12.024.

10. Saumoy M et al. Endoscopic therapies for gallbladder drainage. Gastrointest Endosc. 2021 Oct;94(4):671-84. doi: 10.1016/j.gie.2021.05.031.

11. Van der Merwe SW et al. Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Feb;54(2):185-205. doi: 10.1055/a-1717-1391.

12. Storm AC et al. Transpapillary gallbladder stent placement for long-term therapy of acute cholecystitis. Gastrointest Endosc. 2021 Oct;94(4):742-8 e1. doi: 10.1016/j.gie.2021.03.025.

13. James TW, Baron TH. Converting percutaneous gallbladder drainage to internal drainage using EUS-guided therapy: A review of current practices and procedures. Endosc Ultrasound. 2018 Mar-Apr;7(2):93-6. doi: 10.4103/eus.eus_110_17.

14. James TW, Baron TH. Transpapillary nasocystic tube placement to allow gallbladder distention for EUS-guided cholecystoduodenostomy. VideoGIE. 2019 Dec;4(12):561-2. doi: 10.1016/j.vgie.2019.08.009.

15. Gilman AJ, Baron TH. Delamination of a lumen-apposing metal stent with tissue ingrowth and stent-in-stent removal. Gastrointest Endosc. 2023 Sep;98(3):451-3. doi: 10.1016/j.gie.2023.04.2087.

16. Teoh AY et al. Outcomes of an international multicenter registry on EUS-guided gallbladder drainage in patients at high risk for cholecystectomy. Endosc Int Open. 2019 Aug;7(8):E964-E973. doi: 10.1055/a-0915-2098.

17. Kalva NR et al. Efficacy and safety of lumen apposing self-expandable metal stents for EUS guided cholecystostomy: A meta-analysis and systematic review. Can J Gastroenterol Hepatol. 2018;2018:7070961. doi: 10.1155/2018/7070961.

18. Khan MA et al. Efficacy and safety of endoscopic gallbladder drainage in acute cholecystitis: Is it better than percutaneous gallbladder drainage? Gastrointest Endosc. 2017 Jan;85(1):76-87 e3. doi: 10.1016/j.gie.2016.06.032.

19. Mohan BP et al. Endoscopic ultrasound-guided gallbladder drainage, transpapillary drainage, or percutaneous drainage in high risk acute cholecystitis patients: a systematic review and comparative meta-analysis. Endoscopy. 2020 Feb;52(2):96-106. doi: 10.1055/a-1020-3932.

20. Jang JW et al. Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology. 2012 Apr;142(4):805-11. doi: 10.1053/j.gastro.2011.12.051.

21. Teoh AYB et al. EUS-guided gallbladder drainage versus laparoscopic cholecystectomy for acute cholecystitis: a propensity score analysis with 1-year follow-up data. Gastrointest Endosc. 2021 Mar;93(3):577-83. doi: 10.1016/j.gie.2020.06.066.

22. Luk SW et al. Endoscopic ultrasound-guided gallbladder drainage versus percutaneous cholecystostomy for high risk surgical patients with acute cholecystitis: a systematic review and meta-analysis. Endoscopy. 2019 Aug;51(8):722-32. doi: 10.1055/a-0929-6603.

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Author(s)

Introduction

Techniques & Tips

ET-GBD

During ERCP, after successful cannulation of the bile duct, attempted wire cannulation of the cystic duct is performed.

A cholangiogram, which clearly delineates the insertion of the cystic duct into the main bile duct, can enhance cannulation success. Rotatable fluoroscopy can facilitate identification.

After anatomy is clear, wire access is often best achieved using a sphincterotome or stone retrieval (occlusion) balloon.

The balloon, once inflated, can be pulled downward to establish traction on the main bile duct, which can straighten the approach.

After superficial wire engagement into the cystic duct, the accessory used can be slowly advanced into the cystic duct to stabilize the catheter and then navigate the valves of Heister to reach the gallbladder lumen.

If a stone is encountered that cannot be extracted or traversed by a guidewire, cholangioscopy with electrohydraulic lithotripsy can be pursued.
After the guidewire has entered the gallbladder, a 5 French or 7 French plastic double pigtail stent is placed. Typical lengths are 9-15 cm.

Some authors prefer to use two side-by-side plastic stents.¹² This has been shown retrospectively to enhance the long term clinical success of ET-GBD but with additional technical difficulty.

This stent can remain in place indefinitely and need not be exchanged, though it should be removed just prior to CCY if pursued. Alternatively, the surgeon can be alerted to its presence and, if comfortable, it can be removed intraoperatively.

EUS-GBD

Use of fluoroscopy is optional but can enhance technical success in selected situations.
Conversion, or internalization, of PC is reasonable and can enhance patient quality of life.¹³
If the gallbladder wall is not in close apposition to the duodenal (or gastric) wall, consider measuring the distance.

If there is difficulty locating the gallbladder, it may be decompressed or small (particularly if PC or a partial CCY has already been performed).

Attempt to confirm location within the duodenum prior to puncture, as gastric origins can pose unique ramifications (i.e. potential for partial gastric outlet obstruction, obstruction of LAMS with food debris, etc.).

It can be easy to mistake an unintentional pre-pyloric position for a position within the duodenum since the working channel is behind (proximal to) the echoprobe.

Turning off Doppler flow prior to advancement of the cautery enhanced LAMS can reduce obscurement of views on entry into the gallbladder. Lack of certainty about entry or misdeployment after presumed entry herald the most challenging aspect of EUS-GBD.

Utilization of a previously placed guidewire or advancement of one preloaded into the LAMS can aid in both enhancing confidence in location and assist with salvage maneuvers, if needed.

After successful deployment of the LAMS we routinely place a double pigtail plastic stent through it (typically 7 French by 4 cm) to maintain patency. This may also prevent bleeding from the LAMS flange abrading the wall of either lumen.
We routinely exchange the LAMS for two double pigtail plastic stents (typically 7 French by 4 cm) 4 weeks after initial placement especially when there is a more than modest residual stone burden (data in press). These plastic stents can remain in place indefinitely.

LAMS Misdeployment Salvage Tips

Salvage techniques can vary from simple to complex.
If a wire is in place, it can be used to balloon or catheter dilate the tract and place a FCSEMS traversing the gallbladder and duodenal/gastric lumens. A similar approach can be used if the LAMS deployed on only one side (gallbladder or duodenum/stomach) and the other flange is within the peritoneum.
The most challenging scenario to salvage is if the LAMS is misdeployed or becomes dislodged and no wire is present. This is why the use of a guidewire, even if preloaded into the LAMS and placement is freehand, is essential for EUS-GBD. A potential technique is to balloon dilate the duodenal/gastric defect and drive the endoscope into the peritoneum to reconnect that lumen to the gallbladder defect or LAMS, depending on the site of misdeployment. Doing so requires a high degree of commitment and skill and should not be done casually.
If uncertainty remains or if misdeployment has occurred and salvage attempts have failed, consider closure of the duodenal/gastric defect and conversion to ET-GBD.

This may both treat the initial procedural indication and assist with what is essentially a large bile leak, which might also require percutaneous therapy for non-surgical management.

For endoscopists with limited experience at salvage techniques, it is reasonable for the threshold for conversion to be low, assuming experience with and confidence in ET-GBD is high.
If salvage is successful but ambiguity remains, consider obtaining a cholangiogram via the LAMS to confirm positioning and absence of leak.

Adverse Events

Comparisons Between Techniques

Conclusion

References

Introduction

Techniques & Tips

ET-GBD

During ERCP, after successful cannulation of the bile duct, attempted wire cannulation of the cystic duct is performed.

A cholangiogram, which clearly delineates the insertion of the cystic duct into the main bile duct, can enhance cannulation success. Rotatable fluoroscopy can facilitate identification.

After anatomy is clear, wire access is often best achieved using a sphincterotome or stone retrieval (occlusion) balloon.

The balloon, once inflated, can be pulled downward to establish traction on the main bile duct, which can straighten the approach.

After superficial wire engagement into the cystic duct, the accessory used can be slowly advanced into the cystic duct to stabilize the catheter and then navigate the valves of Heister to reach the gallbladder lumen.

If a stone is encountered that cannot be extracted or traversed by a guidewire, cholangioscopy with electrohydraulic lithotripsy can be pursued.
After the guidewire has entered the gallbladder, a 5 French or 7 French plastic double pigtail stent is placed. Typical lengths are 9-15 cm.

Some authors prefer to use two side-by-side plastic stents.¹² This has been shown retrospectively to enhance the long term clinical success of ET-GBD but with additional technical difficulty.

This stent can remain in place indefinitely and need not be exchanged, though it should be removed just prior to CCY if pursued. Alternatively, the surgeon can be alerted to its presence and, if comfortable, it can be removed intraoperatively.

EUS-GBD

Use of fluoroscopy is optional but can enhance technical success in selected situations.
Conversion, or internalization, of PC is reasonable and can enhance patient quality of life.¹³
If the gallbladder wall is not in close apposition to the duodenal (or gastric) wall, consider measuring the distance.

If there is difficulty locating the gallbladder, it may be decompressed or small (particularly if PC or a partial CCY has already been performed).

Attempt to confirm location within the duodenum prior to puncture, as gastric origins can pose unique ramifications (i.e. potential for partial gastric outlet obstruction, obstruction of LAMS with food debris, etc.).

It can be easy to mistake an unintentional pre-pyloric position for a position within the duodenum since the working channel is behind (proximal to) the echoprobe.

Turning off Doppler flow prior to advancement of the cautery enhanced LAMS can reduce obscurement of views on entry into the gallbladder. Lack of certainty about entry or misdeployment after presumed entry herald the most challenging aspect of EUS-GBD.

Utilization of a previously placed guidewire or advancement of one preloaded into the LAMS can aid in both enhancing confidence in location and assist with salvage maneuvers, if needed.

After successful deployment of the LAMS we routinely place a double pigtail plastic stent through it (typically 7 French by 4 cm) to maintain patency. This may also prevent bleeding from the LAMS flange abrading the wall of either lumen.
We routinely exchange the LAMS for two double pigtail plastic stents (typically 7 French by 4 cm) 4 weeks after initial placement especially when there is a more than modest residual stone burden (data in press). These plastic stents can remain in place indefinitely.

LAMS Misdeployment Salvage Tips

Salvage techniques can vary from simple to complex.
If a wire is in place, it can be used to balloon or catheter dilate the tract and place a FCSEMS traversing the gallbladder and duodenal/gastric lumens. A similar approach can be used if the LAMS deployed on only one side (gallbladder or duodenum/stomach) and the other flange is within the peritoneum.
The most challenging scenario to salvage is if the LAMS is misdeployed or becomes dislodged and no wire is present. This is why the use of a guidewire, even if preloaded into the LAMS and placement is freehand, is essential for EUS-GBD. A potential technique is to balloon dilate the duodenal/gastric defect and drive the endoscope into the peritoneum to reconnect that lumen to the gallbladder defect or LAMS, depending on the site of misdeployment. Doing so requires a high degree of commitment and skill and should not be done casually.
If uncertainty remains or if misdeployment has occurred and salvage attempts have failed, consider closure of the duodenal/gastric defect and conversion to ET-GBD.

This may both treat the initial procedural indication and assist with what is essentially a large bile leak, which might also require percutaneous therapy for non-surgical management.

For endoscopists with limited experience at salvage techniques, it is reasonable for the threshold for conversion to be low, assuming experience with and confidence in ET-GBD is high.
If salvage is successful but ambiguity remains, consider obtaining a cholangiogram via the LAMS to confirm positioning and absence of leak.

Adverse Events

Comparisons Between Techniques

Conclusion

References

Publications

GI and Hepatology News

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Endoscopy, Pancreas, & Biliary Tract

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>166270</fileName> <TBEID>0C04DAB2.SIG</TBEID> <TBUniqueIdentifier>MD_0C04DAB2</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20231218T153251</QCDate> <firstPublished>20240125T105623</firstPublished> <LastPublished>20240125T105623</LastPublished> <pubStatus qcode="stat:"/> <embargoDate>20240201T000000</embargoDate> <killDate/> <CMSDate>20240201T000000</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Gilman and Baron</byline> <bylineText>ANDREW J. GILMAN AND TODD H. BARON</bylineText> <bylineFull>ANDREW J. GILMAN AND TODD H. BARON</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>Feature</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>this article will focus on ET-GBD and EUS-GBD for the primary treatment of cholecystitis or symptomatic cholelithiasis</metaDescription> <articlePDF/> <teaserImage>299669</teaserImage> <teaser>When expertise is available, endoscopic treatment of benign gallbladder disease has a definite role but should be undertaken only by those with the experience and skill to safely do so.</teaser> <title>Endoscopic Management of Benign Gallbladder Disease</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>gih</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">17</term> </publications> <sections> <term>46646</term> <term canonical="true">46653</term> </sections> <topics> <term canonical="true">39702</term> </topics> <links> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012516.jpg</altRep> <description role="drol:caption">Dr. Andrew J. Gilman</description> <description role="drol:credit"/> </link> <link> <itemClass qcode="ninat:picture"/> <altRep contenttype="image/jpeg">images/24012517.jpg</altRep> <description role="drol:caption">Dr. Todd H. Baron</description> <description role="drol:credit"/> </link> </links> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Endoscopic Management of Benign Gallbladder Disease</title> <deck/> </itemMeta> <itemContent> <h2>Introduction</h2> The treatment of benign gallbladder disease has changed substantially in the past decade, but this represents only a snapshot in the evolutionary history of the management of this organ. What began as a problem managed exclusively by open cholecystectomy (CCY) transitioned into a race toward minimally invasive approaches in the 1980s, with advances from gastroenterology, surgery, and radiology. The opening strides were made in 1980 with the first description of percutaneous cholecystostomy (PC) by Dr. R.W. Radder.1 Shortly thereafter, in 1984, Dr. Richard Kozarek first reported the feasibility of selective cystic duct cannulation during endoscopic retrograde cholangiopancreatography (ERCP).2 Subsequent stenting for the treatment of acute cholecystitis (endoscopic transpapillary gallbladder drainage, ET-GBD) was then reported by Tamada et. al. in 1991.3 Not to be outdone, the first laparoscopic cholecystectomy (LC) was completed by Dr. Med Erich Mühe of Germany in 1985.4 More recently, with the expansion of interventional endoscopic ultrasound (EUS), the first transmural EUS-guided gallbladder drainage (EUS-GBD) was described by Dr. Baron and Dr. Topazian in 2007.5 [[{"fid":"299669","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Dr. Andrew J. Gilman, University of North Carolina, Chapel Hill, Division of Gastroenterology & Hepatology","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Andrew J. Gilman"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]] The subsequent advent of lumen apposing metal stents (LAMS) has cemented EUS-GBD in the toolbox of treatment for benign gallbladder disease. Results of a recent prospective multicenter trial, with a Food and Drug Administration–approved protocol and investigational device exemption, have been published, opening the door for the expansion of FDA approved indications for this device.6 [[{"fid":"299670","view_mode":"medstat_image_flush_left","fields":{"format":"medstat_image_flush_left","field_file_image_alt_text[und][0][value]":"Dr. Todd H. Baron, University of North Carolina, Chapel Hill, Division of Gastroenterology & Hepatology","field_file_image_credit[und][0][value]":"","field_file_image_caption[und][0][value]":"Dr. Todd H. Baron"},"type":"media","attributes":{"class":"media-element file-medstat_image_flush_left"}}]] Benign gallbladder disease encompasses both polyps (benign and premalignant) and cholecystitis (acute/chronic, calculous/acalculous), in addition to others. The four management techniques (LC, PC, ET-GBD, and EUS-GBD) have filled integral niches in the management of these patients. Even gallbladder polyps have not been able to escape the reach of endoscopic approaches with the recent description of LAMS-assisted polypectomy as part of a gallbladder preserving strategy.7,8 While EUS-GBD also has been used for biliary decompression in the presence of a patent cystic duct and absence of cholecystitis, this article will focus on ET-GBD and EUS-GBD for the primary treatment of cholecystitis or symptomatic cholelithiasis.9 Both of these techniques have gained wide recognition and/or guideline support for their use from the American Society for Gastrointestinal Endoscopy (ASGE) and the European Society of Gastrointestinal Endoscopy (ESGE).10,11 In addition, there is now one FDA-approved stent device for treatment of acute cholecystitis in patients unfit for surgery. <h2>Techniques & Tips</h2> ET-GBD <ul class="body"> <li>During ERCP, after successful cannulation of the bile duct, attempted wire cannulation of the cystic duct is performed.</li> </ul> A cholangiogram, which clearly delineates the insertion of the cystic duct into the main bile duct, can enhance cannulation success. Rotatable fluoroscopy can facilitate identification. <ul class="body"> <li>After anatomy is clear, wire access is often best achieved using a sphincterotome or stone retrieval (occlusion) balloon.</li> </ul> The balloon, once inflated, can be pulled downward to establish traction on the main bile duct, which can straighten the approach. <ul class="body"> <li>After superficial wire engagement into the cystic duct, the accessory used can be slowly advanced into the cystic duct to stabilize the catheter and then navigate the valves of Heister to reach the gallbladder lumen.</li> </ul> Use of a sphincterotome, which directs toward the patient’s right (most often direction of cystic duct takeoff), is helpful. Angled guidewires are preferable. We often use a 0.035-inch, 260-cm angled hydrophilic wire (GLIDEWIRE; Terumo, Somerset, NJ) to overcome this challenging portion of ET-GBD. If despite the above maneuvers the guidewire has failed to enter the cystic duct, cholangioscopy can be used to identify the orifice and/or stabilize deep wire cannulation. This is often cumbersome, time consuming, does not always produce success, and requires additional expertise. <ul class="body"> <li>If a stone is encountered that cannot be extracted or traversed by a guidewire, cholangioscopy with electrohydraulic lithotripsy can be pursued.</li> <li>After the guidewire has entered the gallbladder, a 5 French or 7 French plastic double pigtail stent is placed. Typical lengths are 9-15 cm.</li> </ul> Some authors prefer to use two side-by-side plastic stents.12 This has been shown retrospectively to enhance the long term clinical success of ET-GBD but with additional technical difficulty. <ul class="body"> <li>This stent can remain in place indefinitely and need not be exchanged, though it should be removed just prior to CCY if pursued. Alternatively, the surgeon can be alerted to its presence and, if comfortable, it can be removed intraoperatively.</li> </ul> EUS-GBD <ul class="body"> <li>Use of fluoroscopy is optional but can enhance technical success in selected situations.</li> <li>Conversion, or internalization, of PC is reasonable and can enhance patient quality of life.13</li> <li>If the gallbladder wall is not in close apposition to the duodenal (or gastric) wall, consider measuring the distance.</li> </ul> We preferentially use 10-mm diameter by 10-mm saddle length LAMS for EUS-GBD, unless the above distance warrants use of a 15-mm by 15-mm LAMS (AXIOS, Boston Scientific, Marlborough, MA). If the distance is greater than 15 mm, consider searching for an alternative site, using a traditional biliary fully covered self-expandable metal stent (FCSEMS) for longer length, or converting to ET-GBD. Smaller diameter (8 mm) with an 8-mm saddle length can be used as well. The optimal diameter is unknown and also dependent on whether transluminal endoscopic diagnosis or therapy is a consideration. <ul class="body"> <li>If there is difficulty locating the gallbladder, it may be decompressed or small (particularly if PC or a partial CCY has already been performed).</li> </ul> If a cholecystostomy tube is in place, instillation of sterile water via the tube can sometimes improve the target for LAMS placement, though caution should be made to not over-distend the gallbladder. ERCP with placement of a nasobiliary tube into the gallbladder can also serve this purpose and has been previously described.14 The gallbladder can be punctured with a 19-gauge FNA needle to instill sterile water and distend the gallbladder with the added benefit of being able to pass a guidewire, which may enhance procedural safety in difficult cases. However, success of this technique is contingent on fluid remaining within the gallbladder and not transiting out via the cystic duct. Expedient exchange of the FNA needle for the LAMS device may be necessary. <ul class="body"> <li>Attempt to confirm location within the duodenum prior to puncture, as gastric origins can pose unique ramifications (i.e. potential for partial gastric outlet obstruction, obstruction of LAMS with food debris, etc.).</li> </ul> It can be easy to mistake an unintentional pre-pyloric position for a position within the duodenum since the working channel is behind (proximal to) the echoprobe. <ul class="body"> <li>Turning off Doppler flow prior to advancement of the cautery enhanced LAMS can reduce obscurement of views on entry into the gallbladder. Lack of certainty about entry or misdeployment after presumed entry herald the most challenging aspect of EUS-GBD.</li> </ul> Utilization of a previously placed guidewire or advancement of one preloaded into the LAMS can aid in both enhancing confidence in location and assist with salvage maneuvers, if needed. <ul class="body"> <li>After successful deployment of the LAMS we routinely place a double pigtail plastic stent through it (typically 7 French by 4 cm) to maintain patency. This may also prevent bleeding from the LAMS flange abrading the wall of either lumen.</li> <li>We routinely exchange the LAMS for two double pigtail plastic stents (typically 7 French by 4 cm) 4 weeks after initial placement especially when there is a more than modest residual stone burden (data in press). These plastic stents can remain in place indefinitely.</li> </ul> This exchange can be deferred if the patient is not expected to survive until the one-year anniversary of LAMS deployment. After one year the LAMS plastic covering may degrade and pose additional problems.15 LAMS Misdeployment Salvage Tips <ul class="body"> <li>Salvage techniques can vary from simple to complex.</li> <li>If a wire is in place, it can be used to balloon or catheter dilate the tract and place a FCSEMS traversing the gallbladder and duodenal/gastric lumens. A similar approach can be used if the LAMS deployed on only one side (gallbladder or duodenum/stomach) and the other flange is within the peritoneum.</li> <li>The most challenging scenario to salvage is if the LAMS is misdeployed or becomes dislodged and no wire is present. This is why the use of a guidewire, even if preloaded into the LAMS and placement is freehand, is essential for EUS-GBD. A potential technique is to balloon dilate the duodenal/gastric defect and drive the endoscope into the peritoneum to reconnect that lumen to the gallbladder defect or LAMS, depending on the site of misdeployment. Doing so requires a high degree of commitment and skill and should not be done casually.</li> <li>If uncertainty remains or if misdeployment has occurred and salvage attempts have failed, consider closure of the duodenal/gastric defect and conversion to ET-GBD.</li> </ul> This may both treat the initial procedural indication and assist with what is essentially a large bile leak, which might also require percutaneous therapy for non-surgical management. <ul class="body"> <li>For endoscopists with limited experience at salvage techniques, it is reasonable for the threshold for conversion to be low, assuming experience with and confidence in ET-GBD is high.</li> <li>If salvage is successful but ambiguity remains, consider obtaining a cholangiogram via the LAMS to confirm positioning and absence of leak.</li> </ul> <h2>Adverse Events</h2> Both ET-GBD and EUS-GBD should be performed by an endoscopist comfortable with their techniques and the management of their adverse events (AEs). Rates for EUS-GBD AEs in patients at high risk for LC were reported in one international multicenter registry to be 15.3% with a 30-day mortality of 9.2%, with a significant predictor of AE being endoscopist experience less than 25 procedures.16 A meta-analysis also found an overall AE rate of 18.31%, with rates for perforation and stent related AEs (i.e. migration, occlusion, pneumoperitoneum) being 6.71% and 8.16%, respectively.17 For this reason, we recommend that patients with cholecystitis who are deemed to be poor surgical candidates be transferred to a tertiary referral center with expertise in these approaches. Rates of AEs for ET-GBD are similar to that for standard ERCP, with reported ranges of 5%-10.3%.10 <h2>Comparisons Between Techniques</h2> The decision on which technique to utilize for endoscopic management of cholecystitis or symptomatic cholelithiasis depends first and foremost on the expertise and comfort level of the endoscopist. Given the additional training that an advanced endoscopist needs to perform EUS-GBD, combined with the perhaps slightly higher AE rate and permanency of endoscopic cholecystostomy, it is reasonable to proceed with a trial of ET-GBD if confidence is insufficient. However, ET-GBD can certainly be more technically challenging and less effective than EUS-GBD, with lower reported technical and clinical success rates (technical 85.3% vs 93.0%, clinical 95.2% vs 97.3%).18 Despite this, the rate of recurrence of cholecystitis is similar between ET-GBD and EUS-GBD (4.6% vs 4.2%).19 As stated above in the Techniques & Tips section, some authors utilize two plastic stents for ET-GBD for this purpose, though with increased technical difficulty. It is important to remember that these numbers, when paired with AE rates, represent the achievements of expert endoscopists. Discussion with your surgery team is important when deciding modality. If the patient is felt to be a potential candidate for CCY, and EUS-GBD is not being used as a destination therapy, the surgeon may prefer ET-GBD. EUS-GBD may enhance the difficulty of CCY, though at least one study demonstrated that this was no different than PC with similar rates of conversion from LC to open CCY.20 This conversation is most critical for patients who are potential liver transplant candidates. For patients where this is not a consideration there is some evidence to suggest equivalency between LC and EUS-GBD, though certainly EUS-GBD has not yet supplanted LC as the treatment of choice.21 While there may eventually be a shift towards EUS-GBD instead of LC in certain patient groups, what is clearer are the advantages of EUS-GBD over PC. One recent meta-analysis revealed that EUS-GBD has significantly favorable odds of overall adverse events (OR 0.43, 95% CI 0.18-1.00), shorter hospital stay (2.76 less days, 95% CI 0.31-5.20 less days), reinterventions (OR 0.15, 95% CI 0.02-0.98), and unplanned readmissions (OR 0.14, 95% CI 0.03-0.70) compared to PC.22 Beyond the data, though, are the emotional and psychological impacts an external drain can have on a patient. <h2>Conclusion</h2> When expertise is available, endoscopic treatment of benign gallbladder disease has a definite role but should be undertaken only by those with the experience and skill to safely do so. Decision to proceed, especially with EUS-GBD, should be accompanied by conversation and collaboration with surgical teams. If a patient is under consideration for PC instead of LC, it may be worthwhile to seek consultation with a local center with expertise in EUS-GBD or ET-GBD. The adoption of these techniques is part of the paradigm shift, seen broadly throughout medicine, towards minimally invasive interventions, particularly in advanced endoscopy. Dr. Gilman (X <a href="https://twitter.com/a_gilman?lang=en">@a_gilman</a>) and Dr. Baron (X <a href="https://twitter.com/EndoTx">@EndoTx</a>) are with the University of North Carolina, Chapel Hill, Division of Gastroenterology & Hepatology. Dr. Gilman has no relevant financial disclosures. Dr. Baron is a consultant and speaker for Ambu, Boston Scientific, Cook Endoscopy, Medtronic, Olympus America, and W.L. Gore. <h2>References</h2> 1. Radder RW. Ultrasonically guided percutaneous catheter drainage for gallbladder empyema. Diagn Imaging. <a href="https://pubmed.ncbi.nlm.nih.gov/7215096">1980;49:330-333</a>. 2. Kozarek RA. Selective cannulation of the cystic duct at time of ERCP. J Clin Gastroenterol. <a href="https://pubmed.ncbi.nlm.nih.gov/6699392/">1984;6:37-40</a>. 3. Tamada K et al. Efficacy of endoscopic retrograde cholecystoendoprosthesis (ERCCE) for cholecystitis. Endoscopy. <a href="https://pubmed.ncbi.nlm.nih.gov/2009832/">1991;23:2-3</a>. 4. Reynolds W. The first laparoscopic cholecystectomy. JSLS. <a href="https://pubmed.ncbi.nlm.nih.gov/11304004/">2001;5:89-94</a>. 5. Baron TH, Topazian MD. Endoscopic transduodenal drainage of the gallbladder: Implications for endoluminal treatment of gallbladder disease. Gastrointest Endosc. <a href="https://www.giejournal.org/article/S0016-5107(06)02537-5/fulltext">2007 Apr;65(4):735-7</a>. doi: 10.1016/j.gie.2006.07.041. 6. Irani SS et al. Endoscopic ultrasound-guided transluminal gallbladder drainage in patients with acute cholecystitis: A prospective multicenter trial. Ann Surg. <a href="https://journals.lww.com/annalsofsurgery/fulltext/2023/09000/endoscopic_ultrasound_guided_transluminal.37.aspx">2023 Sep 1;278(3):e556-e562</a>. doi: 10.1097/SLA.0000000000005784. 7. Shen Y et al. Endoscopic ultrasound-guided cholecystostomy for resection of gallbladder polyps with lumen-apposing metal stent. Medicine (Baltimore). <a href="https://journals.lww.com/md-journal/fulltext/2020/10230/endoscopic_ultrasound_guided_cholecystostomy_for.118.aspx">2020 Oct 23;99(43):e22903</a>. doi: 10.1097/MD.0000000000022903. 8. Pang H et al. Endoscopic ultrasound-guided gallbladder endoscopic mucosal resection: A pilot porcine study. Minim Invasive Ther Allied Technol. <a href="https://www.tandfonline.com/doi/full/10.1080/13645706.2022.2153228">2023 Feb;32(1):24-32</a>. doi: 10.1080/13645706.2022.2153228. 9. Imai H et al. EUS-guided gallbladder drainage for rescue treatment of malignant distal biliary obstruction after unsuccessful ERCP. Gastrointest Endosc. <a href="https://www.giejournal.org/article/S0016-5107(15)03257-5/fulltext">2016 Jul;84(1):147-51</a>. doi: 10.1016/j.gie.2015.12.024. 10. Saumoy M et al. Endoscopic therapies for gallbladder drainage. Gastrointest Endosc. <a href="https://www.giejournal.org/article/S0016-5107(21)01401-2/fulltext">2021 Oct;94(4):671-84</a>. doi: 10.1016/j.gie.2021.05.031. 11. Van der Merwe SW et al. Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. <a href="https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-1717-1391">2022 Feb;54(2):185-205</a>. doi: 10.1055/a-1717-1391. 12. Storm AC et al. Transpapillary gallbladder stent placement for long-term therapy of acute cholecystitis. Gastrointest Endosc. <a href="https://www.giejournal.org/article/S0016-5107(21)00264-9/fulltext">2021 Oct;94(4):742-8 e1</a>. doi: 10.1016/j.gie.2021.03.025. 13. James TW, Baron TH. Converting percutaneous gallbladder drainage to internal drainage using EUS-guided therapy: A review of current practices and procedures. Endosc Ultrasound. <a href="https://journals.lww.com/eusjournal/fulltext/2018/07020/converting_percutaneous_gallbladder_drainage_to.7.aspx">2018 Mar-Apr;7(2):93-6</a>. doi: 10.4103/eus.eus_110_17. 14. James TW, Baron TH. Transpapillary nasocystic tube placement to allow gallbladder distention for EUS-guided cholecystoduodenostomy. VideoGIE. <a href="https://www.videogie.org/article/S2468-4481(19)30226-7/fulltext">2019 Dec;4(12):561-2</a>. doi: 10.1016/j.vgie.2019.08.009. 15. Gilman AJ, Baron TH. Delamination of a lumen-apposing metal stent with tissue ingrowth and stent-in-stent removal. Gastrointest Endosc. <a href="https://www.giejournal.org/article/S0016-5107(23)00594-1/fulltext">2023 Sep;98(3):451-3</a>. doi: 10.1016/j.gie.2023.04.2087. 16. Teoh AY et al. Outcomes of an international multicenter registry on EUS-guided gallbladder drainage in patients at high risk for cholecystectomy. Endosc Int Open. <a href="https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-0915-2098">2019 Aug;7(8):E964-E973</a>. doi: 10.1055/a-0915-2098. 17. Kalva NR et al. Efficacy and safety of lumen apposing self-expandable metal stents for EUS guided cholecystostomy: A meta-analysis and systematic review. Can J Gastroenterol Hepatol. <a href="https://www.hindawi.com/journals/cjgh/2018/7070961/">2018;2018:7070961</a>. doi: 10.1155/2018/7070961. 18. Khan MA et al. Efficacy and safety of endoscopic gallbladder drainage in acute cholecystitis: Is it better than percutaneous gallbladder drainage? Gastrointest Endosc. <a href="https://www.giejournal.org/article/S0016-5107(16)30278-4/fulltext">2017 Jan;85(1):76-87 e3</a>. doi: 10.1016/j.gie.2016.06.032. 19. Mohan BP et al. Endoscopic ultrasound-guided gallbladder drainage, transpapillary drainage, or percutaneous drainage in high risk acute cholecystitis patients: a systematic review and comparative meta-analysis. Endoscopy. <a href="https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-1020-3932">2020 Feb;52(2):96-106</a>. doi: 10.1055/a-1020-3932. 20. Jang JW et al. Endoscopic ultrasound-guided transmural and percutaneous transhepatic gallbladder drainage are comparable for acute cholecystitis. Gastroenterology. <a href="https://www.gastrojournal.org/article/S0016-5085(12)00019-4/fulltext?referrer=https%3A%2F%2Fdx.doi.org%2F">2012 Apr;142(4):805-11</a>. doi: 10.1053/j.gastro.2011.12.051. 21. Teoh AYB et al. EUS-guided gallbladder drainage versus laparoscopic cholecystectomy for acute cholecystitis: a propensity score analysis with 1-year follow-up data. Gastrointest Endosc. <a href="https://www.giejournal.org/article/S0016-5107(20)34532-6/fulltext">2021 Mar;93(3):577-83</a>. doi: 10.1016/j.gie.2020.06.066. 22. Luk SW et al. Endoscopic ultrasound-guided gallbladder drainage versus percutaneous cholecystostomy for high risk surgical patients with acute cholecystitis: a systematic review and meta-analysis. Endoscopy. <a href="https://www.thieme-connect.de/products/ejournals/abstract/10.1055/a-0929-6603">2019 Aug;51(8):722-32</a>. doi: 10.1055/a-0929-6603. </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> </itemContent> </newsItem> </itemSet></root>

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October 2023

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Bajaj JS and Nagy LE. Natural History of Alcohol-Associated Liver Disease: Understanding the Changing Landscape of Pathophysiology and Patient Care. Gastroenterology. 2022 Oct;163(4):840-851. doi: 10.1053/j.gastro.2022.05.031. Epub 2022 May 19. PMID: 35598629; PMCID: PMC9509416.

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Chen YI et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6. PMID: 37549753.

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November 2023

Li YK et al. Risk of Postcolonoscopy Thromboembolic Events: A Real-World Cohort Study. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3051-3059.e4. doi: 10.1016/j.cgh.2022.09.021. Epub 2022 Sep 24. PMID: 36167228.

Tome J et al. Bile Acid Sequestrants in Microscopic Colitis: Clinical Outcomes and Utility of Bile Acid Testing. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3125-3131.e2. doi: 10.1016/j.cgh.2023.04.031. Epub 2023 May 10. PMID: 37172800.

Berry SK et al. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28. PMID: 37391055.

December 2023

Kanwal F et al. Risk Stratification Model for Hepatocellular Cancer in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3296-3304.e3. doi: 10.1016/j.cgh.2023.04.019. Epub 2023 Apr 30. PMID: 37390101; PMCID: PMC10661677.

Forss A et al. Patients With Microscopic Colitis Are at Higher Risk of Major Adverse Cardiovascular Events: A Matched Cohort Study. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3356-3364.e9. doi: 10.1016/j.cgh.2023.05.014. Epub 2023 May 26. PMID: 37245713.

Zheng T et al. A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3405-3414.e4. doi: 10.1016/j.cgh.2023.07.008. Epub 2023 Jul 22. PMID: 37482172.

Techniques and Innovations in Gastrointestinal Endoscopy

Rengarajan A and Aadam A. Peroral Endoscopic Myotomy (POEM) and Its Use in Esophageal Dysmotility. Tech Innov Gastrointest Endosc. 2023 Dec 16. doi: 10.1016/j.tige.2023.12.004.

Wang D et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2023 Nov 7. doi: 10.1016/j.tige.2023.10.003

Gastro Hep Advances

Gregory MH et al. Short Bowel Syndrome: Transition of Pediatric Patients to Adult Gastroenterology Care. Gastro Hep Advances. 2023 Sep 8. doi: 10.1016/j.gastha.2023.09.006.

Viser AC et al. Inflammatory Bowel Disease Patients in the Ambulatory Setting Commonly Screen Positive for Malnutrition. Gastro Hep Advances. 2023 Nov 16. doi: 10.1016/j.gastha.2023.11.007.

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2023 AGA Innovation Conference on the Advances in Endosurgery

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Uzma Siddiqui, MD

WASHINGTON, DC — The American Gastroenterological Association Center for GI Innovation and Technology recently held its fifth annual Innovation Conference (formerly Consensus Conference) on the Advances in Endosurgery, November 10 – 11. It was organized and chaired by Amrita Sethi, MD, Columbia University Irving Medical Center—NYP and Sri Komanduri, MD, MS, Feinberg School of Medicine, Northwestern University, Chicago.

The conference brought together gastroenterologists (GIs), surgeons, and industry partners to explore what further collaboration and clinical adoption is needed to advance endosurgical applications. Both GIs and surgeons welcomed potential collaboration especially in developing strategies to promote education and training initiatives, including defining what procedures and techniques are to be included in the endosurgery arena. Jeffrey Potkul, Medtronic Endoscopy, noted that this was a “great forum, format, and discussions — it will take novel approaches such as this conference and new collaboration models to ensure technology innovation in the endoluminal space can reach patients and empower improved outcomes in Gastroenterology.”

2023 AGA Innovation Conference: Advances in Endosurgery attendees.

Topics discussed included third space endoscopy, endobariatric and metabolic endoscopy, and endoscopy related to transluminal access. Exciting new developments in robotic endoscopy were also highlighted with an attempt to understand the value proposition of this innovation in the endoscopy space, as well as successes and failures of past efforts to help guide success going forward. Other issues raised were methods for device development including initiating research studies, how to navigate regulatory processes for Food and Drug Administration approval of new devices, and ongoing issues related to billing and reimbursement. There was consensus around the need for collaboration between all stakeholders to drive innovation and its adoption in the field of endosurgery. This meeting is one of the first of its kind to bring innovators across multiple disciplines together with the intention of moving the entire field of endosurgery forward and encouraging creative solutions.

We would like to thank the members of the AGA Center for GI Innovation and Technology Committee and attendees who made this year’s conference a success. The conference was supported by independent grants from Boston Scientific Corporation, Cook Medical Inc., Endo Tools Therapeutics, Fujifilm Healthcare Americas Corporation, Intuitive Surgical, Olympus Corporation, and Medtronic.

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AGA aims to increase awareness of exocrine pancreatic insufficiency

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The American Gastroenterological Association (AGA) has published a Clinical Practice Update for managing exocrine pancreatic insufficiency (EPI). The update, which was led by Anna M. Buchner, MD, PhD, University of Pennsylvania, Philadelphia, includes 15 best practice advice statements based on available literature and expert opinion.

“EPI is frequently underdiagnosed and, as a result, patients are often not treated appropriately,” the authors wrote in Gastroenterology. “There is an urgent need to increase awareness of and treatment for this condition.”

To this end, the authors offered guidance spanning the patient journey, with recommendations broadly grouped into four categories: clinical features and risk factors, diagnostic strategies, treatment approaches, and disease monitoring.

Clinical features and risk factors

The CPU begins by listing the key clinical features of EPI, including bloating, excessive flatulence, fat-soluble vitamin deficiencies, protein-calorie malnutrition, steatorrhea with or without diarrhea, and weight loss.

The authors went on to suggest that EPI should also be considered in patients with high-risk clinical conditions, including previous pancreatic surgery, chronic pancreatitis, cystic fibrosis, pancreatic ductal adenocarcinoma, and relapsing acute pancreatitis.

Similarly, suspicion should be increased for individuals with moderate-risk clinical conditions, such as prior intestinal surgery, Zollinger-Ellison syndrome, longstanding diabetes mellitus, and duodenal diseases such as celiac and Crohn’s disease.

Diagnostic strategies

The primary diagnostic tool for EPI is the fecal elastase test, according to the update. Levels below 100 mcg/g indicate EPI, whereas levels between 100-200 mcg/g are considered indeterminate. The investigators noted that this test can be conducted even during pancreatic enzyme replacement therapy (PERT).

Other tests for EPI are rarely used, such as fecal fat testing, which must be performed on a high-fat diet, and quantitative testing, which is generally impractical for routine clinical use.

The authors also noted that a therapeutic trial of PERT is an unreliable method for diagnosing EPI.

“Patients with nonspeciﬁc symptoms, such as bloating, excess gas, and foul-smelling or ﬂoating stools may note some improvement in these symptoms while taking PERT, but these symptoms are nonspeciﬁc and symptomatic changes may be a placebo effect or masking other disorders, such as celiac disease, causing delays in a correct diagnosis,” they wrote.

While cross-sectional imaging methods such as CT scans, MRI, and endoscopic ultrasound play a significant role in detecting other pancreatic diseases, they cannot identify EPI. Breath tests and direct pancreatic function tests do hold promise, but they are not widely available in the United States.

Treatment strategies

Once EPI is diagnosed, treatment with PERT is indicated to prevent complications related to fat malabsorption and malnutrition.

PERT formulations are all equally effective at equivalent doses, according to the update, but non–enteric-coated preparations require concurrent H2 or proton pump inhibitor therapy. PERT should be taken during meals, with an initial adult dose of at least 40,000 USP units of lipase during each meal. Half that dose may be considered for snacks, with further dosage refinements based on meal size and fat content.

Dietary modifications may include supplementation with fat-soluble vitamins alongside smaller, more frequent, low- to moderate-fat meals. Very-low-fat diets should be avoided, the authors cautioned.

Surveillance

EPI treatment success can be identified by reduction in steatorrhea and associated gastrointestinal symptoms, as well as weight gain, improved muscle mass and function, and enhanced fat-soluble vitamin levels, Dr. Whitcomb and colleagues wrote, noting that a dual-energy x-ray absorptiometry scan also should be performed at baseline, then repeated every 1-2 years.

The update was commissioned and approved by the AGA. The investigators disclosed relationships with AbbVie, Nestlé, Regeneron, and others.

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Once EPI is diagnosed, treatment with PERT is indicated to prevent complications related to fat malabsorption and malnutrition.

Surveillance

The update was commissioned and approved by the AGA. The investigators disclosed relationships with AbbVie, Nestlé, Regeneron, and others.

Clinical features and risk factors

Diagnostic strategies

Treatment strategies

Once EPI is diagnosed, treatment with PERT is indicated to prevent complications related to fat malabsorption and malnutrition.

Surveillance

The update was commissioned and approved by the AGA. The investigators disclosed relationships with AbbVie, Nestlé, Regeneron, and others.

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FDA clears AI-assisted colonoscopy device

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The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

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In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

A version of this article first appeared on Medscape.com.

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The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

FDA_icon_web.jpg

A version of this article first appeared on Medscape.com.

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

FDA_icon_web.jpg

A version of this article first appeared on Medscape.com.

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