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Recent advancements in artificial intelligence (AI) have significantly impacted the field of gastrointestinal (GI) endoscopy, with applications spanning a wide range of clinical indications. The central goals for AI in GI endoscopy are to improve endoscopic procedural performance and quality assessment, optimize patient outcomes, and reduce administrative burden. Despite early progress, such as Food and Drug Administration approval of the first computer-aided polyp detection system in 2021, there are numerous important challenges to be faced on the path toward broader adoption of AI algorithms in clinical endoscopic practice., Competing Interests: Disclosures C. Labaki: None. E.N. Uche-Anya: None. T.M. Berzin: consultant for Medtronic, Wision AI, RSIP Vision, Boston Scientific., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background and Aim: Multiple computer-aided detection (CADe) software have now achieved regulatory approval in the US, Europe, and Asia and are being used in routine clinical practice to support colorectal cancer screening. There is uncertainty regarding how different CADe algorithms may perform. No objective methodology exists for comparing different algorithms. We aimed to identify priority scoring metrics for CADe evaluation and comparison., Methods: A modified Delphi approach was used. Twenty-five global leaders in CADe in colonoscopy, including endoscopists, researchers, and industry representatives, participated in an online survey over the course of 8 months. Participants generated 121 scoring criteria, 54 of which were deemed within the study scope and distributed for review and asynchronous email-based open comment. Participants then scored criteria in order of priority on a 5-point Likert scale during ranking round one. The top eleven highest-priority criteria were re-distributed, with another opportunity for open-comment, followed by a final round of priority scoring to identify the final 6 criteria., Results: Mean priority scores for the 54 criteria ranged from 2.25 to 4.38 following the first ranking round. The top eleven criteria following ranking round one yielded mean priority scores ranging from 3.04 to 4.16. The final six highest priority criteria were 1) sensitivity (average = 4.16) and separate & independent validation of the CADe algorithm (4.16), 3) adenoma detection rate (4.08), 4) false positive rate (4.00), 5) latency (3.84), and 6) adenoma miss rate (3.68)., Conclusions: This is the first reported international consensus statement of priority scoring metrics for CADe in colonoscopy. These scoring criteria should inform CADe software development and refinement. Future research should validate these metrics on a benchmark video data set to develop a validated scoring instrument., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and study aims Use of fluoroscopy in gastrointestinal endoscopy is an essential aid in advanced endoscopic interventions. However, it also raises concerns about radiation exposure. This study aimed to develop consensus-based statements for safe and effective use of fluoroscopy in gastrointestinal endoscopy, prioritizing the safety and well-being of healthcare workers and patients. Methods A modified Delphi approach was employed to achieve consensus over three rounds of surveys. Proposed statements were generated in Round 1. In the second round, panelists rated potential statements on a 5-point scale, with consensus defined as ≥80% agreement. Statements were subsequently prioritized in Round 3, using a 1 (lowest priority) to 10 (highest priority) scale. Results Forty-six experts participated, consisting of 34 therapeutic endoscopists and 12 endoscopy nurses from six continents, with an overall 45.6% female representation (n = 21). Forty-three item statements were generated in the first round. Of these, 31 statements achieved consensus after the second round. These statements were categorized into General Considerations (n = 6), Education (n = 10), Pregnancy (n = 4), Family Planning (n = 2), Patient Safety (n = 4), and Staff Safety (n = 5). In the third round, accepted statements received mean priority scores ranging from 7.28 to 9.36, with 87.2% of statements rated as very high priority (mean score ≥ 9). Conclusions This study presents consensus-based statements for safe and effective use of fluoroscopy in gastrointestinal endoscopy, addressing the well-being of healthcare workers and patients. These consensus-based statements aim to mitigate risks associated with radiation exposure while maintaining benefits of fluoroscopy, ultimately promoting a culture of safety in healthcare settings., Competing Interests: Conflict of Interest Tyler Berzin - Consultant for: Medtronic, Boston Scientific, Wision AI, Microtech. Alan N. Barkun - Consultant for Olympus Inc and Medtronic Inc. Cecilia Binda – Lecturer for Steris, Fujifilm, Boston Scientific, Q3 Medical. Alessandro Fugazza – Consultant for Boston Scientific. Rogier P. Voermans - Consultancy and research grant for Boston Scientific, Research grant Prion Medical; Consultancy fee form from Cook Medical. Lecturer Viatris and Zambon. Nauzer Forbes – Speaker for Boston Scientific, Pentax Medical. Consultant for Boston Scientific, Pentax Medical and AstraZeneca. Mariano Villarroel – Consultant for Boston Scientific. Yen-I Chen – Consultant for Boston Scientific. President of Chess Medical. Robert Bechara – Consultant for Olympus, Pentax, Vantage, Medtronic, Pendopharm. Payal Saxena – Consultant for Boston Scientific, Ambu, Erbe. Amrita Sethi – Consultant for Boston Scientific, Interscope, Medtronic, Olympus; Research Support for Boston Scientific, Fujifilm and ERBE. Cesare Hassan: Fujifilm Co. (consultancy); Medtronic Co. (consultancy). Alessandro Repici: Fujifilm Co. (consultancy); Olympus Corp (consultancy); Medtronic Co. (consultancy). Bret Peterson – Consultant for Olympus, Pentax. Investigator for Boston Scientific and Ambu. Silvia Carrara – Consultant for Olympus and Aboca. Jeffrey D. Mosko – Speaker for Boston Scientific, Pendopharm, SCOPE rounds, Vantage, Medtronic. Medical Advisory Board for Pendopharm, Boston Scientific, Janssen, Pentax, Fuji. Grants and Research support from CAG. Christopher W. Teshima – Speaker for Medtronic and Boston Scientific, Consultant for Boston Scientific. Gary R. May – Consultant for Olympus. Speaker for Pentax, Fuji and Medtronic. Samir C Grover –Research grants and personal fees from AbbVie and Ferring Pharmaceuticals, personal fees from Takeda, Sanofi, and BioJAMP, education grants from Janssen, and has equity in Volo Healthcare. All the authors have no relevant financial disclosures or conflicts of interest to declare., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Introduction: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is frequently used to risk-stratify pancreatic cystic lesions (PCLs). Rising PCL incidence and developments in tissue acquisition and specimen analysis necessitate updated appraisal of EUS-FNA safety, particularly the risk of postprocedure pancreatitis, the most common EUS-FNA-related adverse event. Our systematic review aims to accurately quantify the risk of EUS-FNA-related pancreatitis to best inform decisions regarding EUS-FNA's optimal role in PCL workup., Methods: We performed systematic searches in 4 databases from inception to April 2024 for original English-language studies investigating EUS-FNA-related pancreatitis. We extracted data on demographics and EUS-FNA-related pancreatitis risk, severity, and risk factors. These were meta-analyzed through the DerSimonian Laird Method using a random-effects model. Meta-regression of pancreatitis risk was performed to delineate associations with clinical and procedural characteristics., Results: Sixty-four studies comprised 8,086 patients and reported 110 EUS-FNA-related pancreatitis events. Pooled risk of EUS-FNA-related pancreatitis was 1.4% (95% confidence intervals, -0.8% to 3.5%; I2 = 0.00), which was predominantly of mild severity (67%) and uniformly nonfatal. Pancreatitis risk lacked significant association with sample size, age, sex, cyst size, needle caliber, or passes, although we noted trends toward higher risk in studies published after 2015, those using higher gauge needles (19 G vs 22 G/25 G), and those performing EUS-guided through-the-needle biopsy., Discussion: We note with high certainty that pancreatitis after EUS-FNA of PCLs is infrequent and mild in severity with no mortality in the included cohort. EUS-guided through-the-needle biopsy may serve as a significant risk factor for EUS-FNA-related pancreatitis risk; however, further studies are needed to delineate other predisposing characteristics., (Copyright © 2024 by The American College of Gastroenterology.)

Background and Aims: Training in interventional endoscopy is offered by nonaccredited advanced endoscopy fellowship programs (AEFPs). The number of these programs has increased dramatically with a concurrent increase in the breadth and complexity of interventional endoscopy procedures. Accreditation is governed by competency-based education, yet what constitutes a "high-quality" nonaccredited AEFP has not been defined. Using an evidence-based consensus process, we aimed to establish standards for AEFPs., Methods: The RAND UCLA appropriateness method, a well-described modified Delphi process to develop quality indicators, was used. A task force established by the American Society for Gastrointestinal Endoscopy drafted potential quality indicators (structure, process, and outcome) in 6 categories: activity preceding training; structure of AEFPs; training in ERCP, EUS, and EMR; and luminal stent placement. Three rounds of iterative feedback from 20 experts were conducted. Round 0 involved discussion of project details. In round 1, experts independently ranked proposed quality indicators on a 9-point interval scale ranging from highly inappropriate (1) to highly appropriate (9). Next, proposed quality indicators were discussed and reworded in a group meeting followed by round 2, in which experts independently reranked proposed quality indicators and provided benchmarks (when applicable). The median score for each quality indicator was calculated. Mean absolute deviation from the median was calculated, and appropriateness of potential quality indicators was assessed using the BIOMED concerted action on appropriateness definition, P value method, and interpercentile range adjusted for symmetry definition. A quality indicator was deemed appropriate if the median score was ≥7 and met criteria for appropriateness using all 3 defined statistical methods., Results: Of 89 proposed quality indicators, 37 statements met criteria as appropriate for a quality indicator (activity preceding training, 2; structure of AEFPs, 10; training in ERCP, 7; training in EUS, 8; training in EMR, 7; luminal stent placement, 3). Minimum thresholds were defined for 19 relevant quality indicators for number of trainers, procedures during fellowship, and procedures before assessment of competence. Among the final appropriate quality indicators were that all trainees should undergo qualitative and quantitative competence assessments using validated tools at least quarterly with documented feedback throughout the training period and that trainees should track outcomes and relevant quality metrics for specific procedures., Conclusions: This consensus process using validated methodology established standards for an AEFP in an effort to ensure adequate training in the most commonly taught interventional endoscopic procedures (ERCP, EUS, EMR, and luminal stent placement) during fellowship. An important component of an AEFP is the use of competency-based assessments that are compliant with the Accreditation Council for Graduate Medical Education's Next Accreditation System, with the goal of ensuring that trainees achieve specific milestones in their progression to achieving cognitive and technical competency., Competing Interests: Disclosure The following authors disclosed financial relationships: G. A. Cote: Consultant for Interpace Diagnostics and Olympus Corporation; research support from Abbvie Pharmaceuticals. R. N. Keswani: Consultant for Medtronic and Boston Scientific. R. H. Yadlapati: Consultant for Medtronic, Phathom Pharmaceuticals, and StatLinkMD; research support from Ironwood Pharmaceuticals; advisory board with stock options in RJS Mediagnostix. T. M. Berzin: Consultant for Medtronic, Boston Scientific, Wision AI, Magentiq Eye, and RSIP Vision. P. Chahal: Consultant for Boston Scientific and Medtronic. J. Cohen: Consultant for Olympus America and Micro-Tech; stock owner in GI Windows, Virtual Health Partners, and Rom-Tech; owner of MD Medical Navigators. W. J. Coyle: Speaker for Abbvie, Pharm and Regeneron, and Pharm D. Early: Scientific advisory board for Guardant Health. N. M. Guda: Consultant for Boston Scientific and Hemostasis Inc LLC; speaker for Lupin Pharmaceuticals, India. S. Inamdar: Consultant for Pentax Medical. E. J. Shin: Consultant for Boston Scientific. U. D. Siddiqui: Consultant and speaker for Olympus, Boston Scientific, ConMed, Medtronic, and Cook Medical; research support from Olympus and Boston Scientific. All other authors disclosed no financial relationships., (Copyright © 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background and Aims: Endoscopic retrograde cholangiopancreatography (ERCP) is the standard of care for the management of choledocholithiasis but carries risk of complications which may result in significant morbidity and mortality. While currently available guidelines endorse the use of ERCP for the management of symptomatic common bile duct stones, the need for ERCP in incidentally found asymptomatic choledocholithiasis is more controversial, and practice varies on a geographic and institutional level. This systematic review and meta-analysis is conducted to compare post-ERCP adverse events between asymptomatic and symptomatic choledocholithiasis patients., Methods: We searched PubMed/Embase/Web of Science databases to include all studies comparing post-ERCP outcomes between asymptomatic and symptomatic choledocholithiasis patients. The primary outcome was post-ERCP pancreatitis (PEP), while secondary outcomes included post-ERCP cholangitis, bleeding, and perforation. We calculated pooled risk ratios (RR) and 95% confidence intervals (CIs) using the Mantel-Haenszel method within a random-effect model., Results: Our analysis included six observational studies, totaling 2,178 choledocholithiasis patients (392 asymptomatic and 1786 symptomatic); 53% were female. Asymptomatic patients exhibited a higher risk of PEP compared with symptomatic patients (11.7% versus 4.8%; RR 2.59, 95% CI 1.56-4.31, p ≤ 0.001). No significant difference was observed in post-ERCP cholangitis, bleeding, or perforation rates between the two groups., Conclusions: Asymptomatic patients with choledocholithiasis appear to have a higher risk of PEP than symptomatic patients, while the risk of other post-ERCP adverse events is similar between the two groups. Interventional endoscopists should thoroughly discuss potential adverse events (particularly PEP) with asymptomatic patients before performing ERCP and utilize PEP-prevention measures more liberally in this subgroup of patients., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background and study aims The Bethesda ERCP Skill Assessment Tool (BESAT) is a video-based assessment tool of technical endoscopic retrograde cholangiopancreatography (ERCP) skill with previously established validity evidence. We aimed to assess the discriminative validity of the BESAT in differentiating ERCP skill levels. Methods Twelve experienced ERCP practitioners from tertiary academic centers were asked to blindly rate 43 ERCP videos using the BESAT. ERCP videos consisted of native biliary cannulation and sphincterotomy and were recorded from 10 unique endoscopists of various ERCP experience (from advanced endoscopy fellow to > 10 years of ERCP experience). Inter-rater reliability, discriminative validity, and internal structure validity were subsequently assessed. Results The BESAT was found to reliably differentiate between endoscopists of varying levels of ERCP experience with experienced ERCPists scoring higher than novice ERCPists in 11 of 13 (85%) instrument items. Inter-rater reliability for BESAT items ranged from good to excellent (intraclass correlation range: 0.86 to 0.93). Internal structure validity was assessed with item-total correlations ranging from 0.53 to 0.83. Conclusions Study findings demonstrate that the BESAT, a video-based ERCP skill assessment tool, has high inter-rater reliability and has discriminative validity in differentiating novice from expert ERCP skill. Further investigations are needed to determine the role of video-based assessment in improving trainee learning curves and patient outcomes., Competing Interests: Conflict of Interest The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).)

Background and Aims: The application of endoscopic suturing has revolutionized defect closures. Conventional over-the-scope suturing necessitates removal of the scope, placement of the device, and reinsertion. A single channel, single sequence, through-the-scope suturing device has been developed to improve this process. This study aims to describe the efficacy, feasibility, and safety of a through-the-scope suturing device for gastrointestinal defect closure., Methods: This was a retrospective multicenter study involving 9 centers of consecutive adult patients who underwent suturing using the X-Tack Endoscopic HeliX Tacking System (Apollo Endosurgery). The primary outcomes were technical success and long-term clinical success. Secondary outcomes included adverse events, recurrence, and reintervention rates., Results: In all, 56 patients (mean age 53.8, 33 women) were included. Suturing indications included fistula repair (n=22), leak repair (n=7), polypectomy defect closure (n=12), peroral endoscopic myotomy (POEM) site closure (n=7), perforation repair (n=6), and ulcers (n=2). Patients were followed at a mean duration of 74 days. Overall technical and long-term clinical success rates were 92.9% and 75%, respectively. Both technical and clinical success rates were 100% for polypectomies, POEM-site closures, and ulcers. Success rates were lower for the repair of fistulas (95.5% technical, 54.5% clinical), leaks (57.1%, 28.6%), and perforations (100%, 66.7%). No immediate adverse events were noted., Conclusion: This novel, through-the-scope endoscopic suturing system, is a safe and feasible method to repair defects that are ≤3 cm. The efficacy of this device may be better suited for superficial defects as opposed to full-thickness defects. Larger defects will need more sutures and probably a double closure technique to provide a reinforcement layer., Competing Interests: N.B.M. is a consultant for Boston Scientific. H.A. is a consultant for Olympus America, Boston Scientific, and Fujifilm Medical Systems. M.T.M. is a consultant for Boston Scientific. S.M. is a consultant for Boston Scientific and Conmed. R.Z.S. is a consultant for Boston Scientific, Olympus, Cook Medical, and Surgical Intuitive. The remaining authors declare no conflicts of interest., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: Dr Holzwanger is a consultant for Virgo. Dr Gabr is a consultant for Medtronic, ConMed, Olympus, Boston Scientific, Fuji, and AdaptivEndo. Dr Berzin is a consultant for Boston Scientific, Medtronic, and Fuji. Dr Pleskow is a consultant for Boston Scientific, Medtronic, Olympus, and Fuji. All other authors disclosed no financial relationships relevant to this publication.

Video 1The mass was identified at the upper- to mid-esophagus, 25 cm from the central incisors. No varices were seen on further examination of the esophagus. A 4-mm injector force needle was used to create a large submucosal injection using BlueBoost lifting agent proximal to the mass. A longitudinal mucosal incision was then made using the hybrid T-type electrocautery knife, 20 cm from the central incisors.The cutting current was the preset Endocut Q mode, and the coagulation setting was spray coag mode, effect 2 and 40 W.Next, tunnel creation by submucosal dissection was performed with a focus on keeping the submucosal space as clean as possible. Carbon dioxide was used for insufflation to prevent pneumoperitoneum.A smooth-surfaced oval mass was identified originating from the muscularis propria layer. Dissection was extended 2 cm distally beyond the mass. Next, resection of the mass was performed. First, the mucosal surface of the mass was dissected. Dissection began at the distal portion, proceeded to the left and right lateral borders, and then continued toward the proximal portion. The mass was dissected away from the muscularis propria.We focused on freeing the mass, ensuring this esophageal mass was intact throughout dissection. The attached bands of muscularis propria at the distal portion were carefully resected completely.Water irrigation was used at this time to ensure better visualization for resection. The remaining attached bands of muscularis propria were resected, ensuring complete en bloc resection. Afterward, the mass was suctioned into the cap and carefully retrieved as shown, and then sent to pathology for processing.The entire defect bed was inspected post-resection, and no perforation or bleeding was identified.The mucosal defect was completely closed with through-the-scope hemostatic clips in a longitudinal fashion beginning with approximation of the defect at the distal portion., Competing Interests: Dr Holzwanger is a consultant for Virgo. Dr Gabr is a consultant for Medtronic, ConMed, Olympus, Boston Scientific, Fuji, and Adaptiv Endo. Dr Berzin is a consultant for Boston Scientific, Medtronic, and Fuji. Dr Pleskow is a consultant for Boston Scientific, Medtronic, Olympus, and Fuji. All other authors disclosed no financial relationships relevant to this publication., (© 2024 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.)

Video 1Endoscopic treatment of a Bouveret syndrome showing and describing the techniques and procedures involved., (© 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.)

Video 1Enhanced suction for removal of esophageal food impaction., (© 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.)

Background: To demonstrate treatment efficacy in Crohn's disease (CD), regulatory authorities require that trials include an endoscopic remission/response end point; however, standardized endoscopic assessment of disease activity, such as the Simple Endoscopic Score for Crohn's Disease (SES-CD), is not typically recorded by clinicians in practice or outside of clinical trials. The novel Simplified Endoscopic Mucosal Assessment for Crohn's Disease (SEMA-CD) was developed to be easy to use in routine clinical practice and as a trial end point. We conducted a study to assess and validate the reliability and feasibility of SEMA-CD as a measure of endoscopic disease activity., Methods: Pre- and post-treatment ileocolonoscopy videos of pediatric (n = 36) and adult (n = 74) CD patients from 2 ustekinumab clinical trials were each scored with SEMA-CD by 2 to 3 professional central readers, blinded to clinical history and other video scorings; the correlation between SEMA-CD and SES-CD previously completed during the trials was assessed. Sensitivity to change, inter- and intrarater reliability, and comparative ease of scoring were also assessed., Results: The SEMA-CD strongly correlated with SES-CD (Spearman ρ = 0.89; 95% confidence interval, 0.86-0.92). Pre- to post-treatment changes in SEMA-CD vs in SES-CD were strongly correlated, and the correlation remained strong between the scores when compared by study population (pediatric, adult), disease severity, and video quality. Intra- and inter-rater reliability were good, and SEMA-CD was rated easier than SES-CD to score 63.0% of the time, although slightly more difficult than SES-CD to score <1.0% of the time., Conclusions: The SEMA-CD is reliable, reproducible, sensitive to change, and easy to use in both pediatric and adult patients with CD., (© 2022 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation.)

Video 1Natural orifice transendoscopic surgery as a rescue for a dislodged lumen-apposing metal stent after EUS-directed transgastric ERCP., (© 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.)

Background and Aims: Large colon polyps removed by EMR can be complicated by delayed bleeding. Prophylactic defect clip closure can reduce post-EMR bleeding. Larger defects can be challenging to close using through-the-scope clips (TTSCs), and proximal defects are difficult to reach using over-the-scope techniques. A novel, through-the-scope suturing (TTSS) device allows direct closure of mucosal defects without scope withdrawal. The goal of this study was to evaluate the rate of delayed bleeding after the closure of large colon polyp EMR sites with TTSS., Methods: A multicenter retrospective cohort study was performed involving 13 centers. All defect closure by TTSS after EMR of colon polyps ≥2 cm from January 2021 to February 2022 were included. The primary outcome was rate of delayed bleeding., Results: A total of 94 patients (52% female; mean age, 65 years) underwent EMR of predominantly right-sided (n = 62 [66%]) colon polyps (median size, 35 mm; interquartile range, 30-40 mm) followed by defect closure with TTSS during the study period. All defects were successfully closed with TTSS alone (n = 62 [66%]) or with TTSS and TTSCs (n = 32 [34%]), using a median of 1 (interquartile range, 1-1) TTSS system. Delayed bleeding occurred in 3 patients (3.2%), with 2 requiring repeated endoscopic evaluation/treatment (moderate)., Conclusion: TTSS alone or with TTSCs was effective in achieving complete closure of all post-EMR defects, despite a large lesion size. After TTSS closure with or without adjunctive devices, delayed bleeding was seen in 3.2% of cases. Further prospective studies are needed to validate these findings before wider adoption of TTSS for large polypectomy closure., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. All rights reserved.)

Background and study aims American Society of Gastrointestinal Endoscopy (ASGE) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines recommend categorizing patients by risk for choledocholithiasis to determine management. The goal of our study was to compare the accuracy of criteria proposed in these guidelines. Patients and methods All patients with suspected choledocholithiasis at our institution were prospectively identified. Based upon initial test results, patients were categorized as low, intermediate, and high risk for choledocholithiasis per ASGE 2010 and 2019, and ESGE criteria. Patients were followed until 30 days post-discharge. Results of endoscopic retrograde cholangiography (ERCP), endoscopic ultrasound, and magnetic resonance cholangiopancreatography were used as criteria standard for choledocholithiasis. The accuracy of each criterion for choledocholithiasis was computed. Results During the study period, 359 consecutive patients with suspected choledocholithiasis were identified, of whom 225 had choledocholithiasis. Median patient age was 69 years and 55.3% were women. ESGE criteria categorized 47.9% as high-risk, lower than ASGE 2010 (62.7%, P <0.01), and 2019 criteria (54.6%, P =0.07). In high-risk patients, choledocholithiasis was noted in 83.1% for ESGE criteria, similar for ASGE 2019 (81.6%, P =0.7) and 2010 criteria (79.1%, P =0.3). The percentage of patients who underwent unnecessary ERCP was 8.1% per ESGE criteria, lower than ASGE 2010 (13.1%, P =0.03), but similar to 2019 criteria (10%, P =0.4). No difference in accuracy for choledocholithiasis was noted among the three criteria. No 30-day readmissions for choledocholithiasis were noted in the low-risk category. Conclusions ESGE and ASGE guidelines have similar accuracy for diagnosis of choledocholithiasis. However, ESGE criteria result in more patients needing additional testing, but also a smaller proportion of patients undergoing unnecessary ERCP., Competing Interests: Conflict of Interest The authors declare that they have no conflict of interest., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).)

Objectives: Meticulous inspection of the mucosa during colonoscopy, represents a lengthier withdrawal time, but has been shown to increase adenoma detection rate (ADR). We investigated if artificial intelligence-aided speed monitoring can improve suboptimal withdrawal time., Methods: We evaluated the implementation of a computer-aided speed monitoring device during colonoscopy at a large academic endoscopy center. After informed consent, patients ≥18 years undergoing colonoscopy between 5 March and 29 April 2021 were examined without the use of the speedometer, and with the speedometer between 29 April and 30 June 2021. All colonoscopies were recorded, and withdrawal time was assessed based on the recordings in a blinded fashion. We compared mean withdrawal time, percentage of withdrawal time ≥6 min, and ADR with and without the speedometer., Results: One hundred sixty-six patients in each group were eligible for analyses. Mean withdrawal time was 9 min and 6.6 s (95% CI: 8 min and 34.8 s to 9 min and 39 s) without the use of the speedometer, and 9 min and 9 s (95% CI: 8 min and 45 s to 9 min and 33.6 s) with the speedometer; difference 2.3 s (95% CI: -42.3-37.7, p  = 0.91). The ADRs were 45.2% (95% CI: 37.6-52.8) without the speedometer as compared to 45.8% (95% CI: 38.2-53.4) with the speedometer ( p  = 0.91). The proportion of colonoscopies with withdrawal time ≥6 min without the speedometer was 85.5% (95% CI: 80.2-90.9) versus 86.7% (95% CI: 81.6-91.9) with the speedometer ( p  = 0.75)., Conclusions: Use of speed monitoring during withdrawal did not increase withdrawal time or ADR in colonoscopy., Clinicaltrials.gov Identifier: NCT04710251.

Deep sedation without tracheal intubation (monitored anaesthesia care) and general anaesthesia with tracheal intubation are commonly used anaesthesia techniques for endoscopic retrograde cholangiopancreatography (ERCP). There are distinct pathophysiological differences between monitored anaesthesia care and general anaesthesia that need to be considered depending on the nature and severity of the patient's underlying disease, comorbidities, and procedural risks. An international group of expert anaesthesiologists and gastroenterologists created clinically relevant questions regarding the merits and risks of monitored anaesthesia care vs general anaesthesia in specific clinical scenarios for planning optimal anaesthetic approaches for ERCP. Using a modified Delphi approach, the group created practical recommendations for anaesthesiologists, with the aim of reducing the incidence of perioperative adverse outcomes while maximising healthcare resource utilisation. In the majority of clinical scenarios analysed, our expert recommendations favour monitored anaesthesia care over general anaesthesia. Patients with increased risk of pulmonary aspiration and those undergoing prolonged procedures of high complexity were thought to benefit from general anaesthesia with tracheal intubation. Patient age and ASA physical status were not considered to be factors for choosing between monitored anaesthesia care and general anaesthesia. Monitored anaesthesia care is the favoured anaesthesia plan for ERCP. An individual risk-benefit analysis that takes into account provider and institutional experience, patient comorbidities, and procedural risks is also needed., (Copyright © 2023 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.)

The number of artificial intelligence (AI) tools for colonoscopy on the market is increasing with supporting clinical evidence. Nevertheless, their implementation is not going smoothly for a variety of reasons, including lack of data on clinical benefits and cost-effectiveness, lack of trustworthy guidelines, uncertain indications, and cost for implementation. To address this issue and better guide practitioners, the World Endoscopy Organization (WEO) has provided its perspective about the status of AI in colonoscopy as the position statement. WEO Position Statement: Statement 1.1: Computer-aided detection (CADe) for colorectal polyps is likely to improve colonoscopy effectiveness by reducing adenoma miss rates and thus increase adenoma detection; Statement 1.2: In the short term, use of CADe is likely to increase health-care costs by detecting more adenomas; Statement 1.3: In the long term, the increased cost by CADe could be balanced by savings in costs related to cancer treatment (surgery, chemotherapy, palliative care) due to CADe-related cancer prevention; Statement 1.4: Health-care delivery systems and authorities should evaluate the cost-effectiveness of CADe to support its use in clinical practice; Statement 2.1: Computer-aided diagnosis (CADx) for diminutive polyps (≤5 mm), when it has sufficient accuracy, is expected to reduce health-care costs by reducing polypectomies, pathological examinations, or both; Statement 2.2: Health-care delivery systems and authorities should evaluate the cost-effectiveness of CADx to support its use in clinical practice; Statement 3: We recommend that a broad range of high-quality cost-effectiveness research should be undertaken to understand whether AI implementation benefits populations and societies in different health-care systems., (© 2023 Japan Gastroenterological Endoscopy Society.)

Video 1Deploying automated machine learning for computer vision projects: a brief introduction for endoscopists., (© 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.)

Background and Aims: Artificial intelligence (AI) tools aimed at improving polyp detection have been shown to increase the adenoma detection rate during colonoscopy. However, it is unknown how increased polyp detection rates by AI affect the burden of patient surveillance after polyp removal., Methods: We conducted a pooled analysis of 9 randomized controlled trials (5 in China, 2 in Italy, 1 in Japan, and 1 in the United States) comparing colonoscopy with or without AI detection aids. The primary outcome was the proportion of patients recommended to undergo intensive surveillance (ie, 3-year interval). We analyzed intervals for AI and non-AI colonoscopies for the U.S. and European recommendations separately. We estimated proportions by calculating relative risks using the Mantel-Haenszel method., Results: A total of 5796 patients (51% male, mean 53 years of age) were included; 2894 underwent AI-assisted colonoscopy and 2902 non-AI colonoscopy. When following U.S. guidelines, the proportion of patients recommended intensive surveillance increased from 8.4% (95% CI, 7.4%-9.5%) in the non-AI group to 11.3% (95% CI, 10.2%-12.6%) in the AI group (absolute difference, 2.9% [95% CI, 1.4%-4.4%]; risk ratio, 1.35 [95% CI, 1.16-1.57]). When following European guidelines, it increased from 6.1% (95% CI, 5.3%-7.0%) to 7.4% (95% CI, 6.5%-8.4%) (absolute difference, 1.3% [95% CI, 0.01%-2.6%]; risk ratio, 1.22 [95% CI, 1.01-1.47])., Conclusions: The use of AI during colonoscopy increased the proportion of patients requiring intensive colonoscopy surveillance by approximately 35% in the United States and 20% in Europe (absolute increases of 2.9% and 1.3%, respectively). While this may contribute to improved cancer prevention, it significantly adds patient burden and healthcare costs., (Copyright © 2023 The Author(s). Published by Elsevier Inc. All rights reserved.)

Video 1., (Copyright © 2023 American Society for Gastrointestinal Endoscopy.)

Bile duct cancer is the second most common primary liver cancer, with most diagnoses occurring in the advanced stages. This leads to a poor survival rate, which means a technique capable of reliably detecting pre-cancer in the bile duct is urgently required. Unfortunately, radiological imaging lacks adequate accuracy for distinguishing dysplastic and benign biliary ducts, while endoscopic techniques, which can directly assess the bile duct lining, often suffer from insufficient sampling. Here, we report an endoscopic optical light scattering technique for clinical evaluation of the malignant potential of the bile duct. This technique employs an ultraminiature spatial gating fiber optic probe compatible with cholangioscopes and endoscopic retrograde cholangiopancreatography (ERCP) catheters. The probe allowed us to investigate the internal cellular composition of the bile duct epithelium with light scattering spectroscopy (LSS) and phenotypic properties of the underlying connective tissue with diffuse reflectance spectroscopy (DRS). In a pilot in vivo double-blind prospective study involving 29 patients undergoing routine ERCP procedures, the technique detected malignant transformation with 97% accuracy, showing that biliary duct pre-cancer can be reliably identified in vivo non-invasively., (© 2023. The Author(s).)

Artificial intelligence (AI) and machine learning (ML) systems are increasingly used in medicine to improve clinical decision-making and healthcare delivery. In gastroenterology and hepatology, studies have explored a myriad of opportunities for AI/ML applications which are already making the transition to bedside. Despite these advances, there is a risk that biases and health inequities can be introduced or exacerbated by these technologies. If unrecognised, these technologies could generate or worsen systematic racial, ethnic and sex disparities when deployed on a large scale. There are several mechanisms through which AI/ML could contribute to health inequities in gastroenterology and hepatology, including diagnosis of oesophageal cancer, management of inflammatory bowel disease (IBD), liver transplantation, colorectal cancer screening and many others. This review adapts a framework for ethical AI/ML development and application to gastroenterology and hepatology such that clinical practice is advanced while minimising bias and optimising health equity., Competing Interests: Competing interests: TMB is a consultant for Wision AI, Docbot AI, Medtronic and Magentiq Eye. FPM is a consultant for Medtronic and receives research funding from Exact Sciences. AA-Y receives research funding from Pfizer and Exact Sciences, and consulting fees from Janssen Pharmaceuticals., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Background & Aims: Artificial intelligence-based computer-aided polyp detection (CADe) systems are intended to address the issue of missed polyps during colonoscopy. The effect of CADe during screening and surveillance colonoscopy has not previously been studied in a United States (U.S.) population., Methods: We conducted a prospective, multi-center, single-blind randomized tandem colonoscopy study to evaluate a deep-learning based CADe system (EndoScreener, Shanghai Wision AI, China). Patients were enrolled across 4 U.S. academic medical centers from 2019 through 2020. Patients presenting for colorectal cancer screening or surveillance were randomized to CADe colonoscopy first or high-definition white light (HDWL) colonoscopy first, followed immediately by the other procedure in tandem fashion by the same endoscopist. The primary outcome was adenoma miss rate (AMR), and secondary outcomes included sessile serrated lesion (SSL) miss rate and adenomas per colonoscopy (APC)., Results: A total of 232 patients entered the study, with 116 patients randomized to undergo CADe colonoscopy first and 116 patients randomized to undergo HDWL colonoscopy first. After the exclusion of 9 patients, the study cohort included 223 patients. AMR was lower in the CADe-first group compared with the HDWL-first group (20.12% [34/169] vs 31.25% [45/144]; odds ratio [OR], 1.8048; 95% confidence interval [CI], 1.0780-3.0217; P = .0247). SSL miss rate was lower in the CADe-first group (7.14% [1/14]) vs the HDWL-first group (42.11% [8/19]; P = .0482). First-pass APC was higher in the CADe-first group (1.19 [standard deviation (SD), 2.03] vs 0.90 [SD, 1.55]; P = .0323). First-pass ADR was 50.44% in the CADe-first group and 43.64 % in the HDWL-first group (P = .3091)., Conclusion: In this U.S. multicenter tandem colonoscopy randomized controlled trial, we demonstrate a decrease in AMR and SSL miss rate and an increase in first-pass APC with the use of a CADe-system when compared with HDWL colonoscopy alone., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Video 1Case description, description of suture pattern and technique, and video demonstrating technique in vivo, follow-up endoscopy, and conclusions., (© 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc.)

Background and Aims: EUS is increasingly used to evaluate patients with liver disease, but its role in assessing hepatic steatosis has not been reported. The goal of our study was to assess the accuracy of EUS for diagnosing hepatic steatosis., Methods: We identified all patients who underwent EUS-guided liver biopsy sampling at our institution. All digitally stored EUS liver images were reviewed by a single radiologist, who rated the severity of liver echogenicity using a 4-point US scale. Liver biopsy specimens for all study patients were reviewed by a single liver pathologist, who rated them for steatosis and fibrosis using Nonalcoholic Steatohepatitis Clinical Research Network criteria. Receiver operator characteristic curves were used to assess the diagnostic accuracy of EUS for hepatic steatosis for all patients and in a subgroup analysis for obese and nonobese patients., Results: During the study period, 76 patients underwent EUS-guided liver biopsy sampling. The average age of study patients was 56.5 years, 50% were women, and 43.2% were obese. The accuracy for EUS for the diagnosis of hepatic steatosis was .8 (95% confidence interval [CI], .7-.89). The accuracy of EUS for the diagnosis of hepatic steatosis in obese patients was .93 (95% CI, .8-.99) and in nonobese patients was .69 (95% CI, .54-.83). For obese patients, EUS had a positive predictive value of 89.7% and a negative predictive value of 75%. The finding of course echotexture on EUS had an accuracy of 79% for the diagnosis of grade 3 fibrosis or cirrhosis., Conclusions: EUS is a useful tool for the diagnosis of hepatic steatosis, particularly in obese patients in whom abdominal US has modest accuracy., (Copyright © 2022. Published by Elsevier Inc.)

Background: The optimal timing of biliary drainage by endoscopic retrograde cholangiopancreatography (ERCP) for patients with acute cholangitis remains controversial. The aim of our study was to determine if ERCP performed within 6 or 12 h of presentation was associated with improved clinical outcomes., Methods: Medical records for all patients with acute cholangitis who underwent ERCP at our institution between 2009 and 2018 were reviewed. Outcomes were compared between those who underwent ERCP within or after 12 h using propensity score framework. Our primary outcome was length of hospitalization. Secondary outcomes included in-hospital mortality, adverse events, ERCP failure, length of ICU stay, organ failure, recurrent cholangitis, and 30-day readmission. In secondary analysis, outcomes for ERCP done within or after 6 h were also compared., Results: During study period, 487 patients with cholangitis were identified, of whom 147 had ERCP within 12 h of presentation. Using propensity score matching, we selected 145 pairs of patients with similar characteristics. Length of hospitalization was similar between ERCP within or after 12 h (135.9 vs 122.1 h, p 0.094). No difference was noted in mortality, ERCP failure, adverse events, need and length of ICU stay, and recurrent cholangitis. However, 30-day readmission rates were lower when ERCP within 12 h (7.6 vs 15.2, p 0.042). No significant difference was noted in aforementioned outcomes between ERCP performed within or after 6 h., Conclusions: ERCP performed within 6 h or 12 h of presentation was not associated with superior clinical outcomes, however, may result in reduced re-hospitalization., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: Pancreatic ductal adenocarcinoma (PDAC) remains a significant health issue. For most patients, there are no options for targeted therapy, and existing treatments are limited by toxicity. The HOPE trial (Harnessing Organoids for PErsonalized Therapy) was a pilot feasibility trial aiming to prospectively generate patient-derived organoids (PDO) from patients with PDAC and test their drug sensitivity and correlation with clinical outcomes., Experimental Design: PDOs were established from a heterogeneous population of patients with PDAC including both basal and classical PDAC subtypes., Results: A method for classifying PDOs as sensitive or resistant to chemotherapy regimens was developed to predict the clinical outcome of patients. Drug sensitivity testing on PDOs correlated with clinical responses to treatment in individual patients., Conclusions: These data support the investigation of PDOs to guide treatment in prospective interventional trials in PDAC., (©2021 American Association for Cancer Research.)

Gastroenterology has been an early leader in bridging the gap between artificial intelligence (AI) model development and clinical trial validation, and in recent years we have seen the publication of several randomized clinical trials examining the role of AI in gastroenterology. As AI applications for clinical medicine advance rapidly, there is a clear need for guidance surrounding AI-specific study design, evaluation, comparison, analysis and reporting of results. Several initiatives are in the publication or pre-publication phase including AI-specific amendments to minimum reporting guidelines for clinical trials, society task force initiatives aimed at priority use cases and research priorities, and minimum reporting guidelines that guide the reporting of clinical prediction models. In this paper, we examine applications of AI in clinical trials and discuss elements of newly published AI-specific extensions to the Consolidated Standards of Reporting Trials and Standard Protocol Items: Recommendations for Interventional Trials statements that guide clinical trial reporting and development. We then review AI applications at the pre-trial level in both endoscopy and other subfields of gastroenterology and explore areas where further guidance is needed to supplement the current guidance available at the pre-trial level., (© 2021 Japan Gastroenterological Endoscopy Society.)

Background and Aims: Image-guided radiation therapy (IGRT) often relies on EUS-guided fiducial markers. Previously used manually backloaded fiducial needles have multiple potential limitations including safety and efficiency concerns. Our aim was to evaluate the efficacy, feasibility, and safety of EUS-guided placement of gold fiducials using a novel preloaded 22-gauge needle compared with a traditional, backloaded 19-gauge needle., Methods: This was a single-center comparative cohort study. Patients with pancreatic and hepatobiliary malignancy who underwent EUS-guided fiducial placement (EUS-FP) between October 2014 and February 2018 were included. The main outcome was the technical success of fiducial placement. Secondary outcomes were mean procedure time, fiducial visibility during IGRT, technical success of IGRT delivery, and adverse events., Results: One hundred fourteen patients underwent EUS-FP during the study period. Of these, 111 patients had successful placement of a minimum of 2 fiducials. Fifty-six patients underwent placement using a backloaded 19-gauge needle and 58 patients underwent placement using a 22-gauge preloaded needle. The mean number of fiducials placed successfully at the target site was significantly higher in the 22-gauge group compared with the 19-gauge group (3.53 ± .96 vs 3.11 ± .61, respectively; P = .006). In the 22-gauge group, the clinical goal of placing 4 fiducials was achieved in 78%, compared with 23% in the 19-gauge group (P < .001). In univariate analyses, gender, age, procedure time, tumor size, and location did not influence the number of successfully placed fiducials. Technical success of IGRT with fiducial tracking was high in both the 19-gauge (51/56, 91%) and the 22-gauge group (47/58, 81%; P = .12)., Conclusions: EUS-FP using a preloaded 22-gauge needle is feasible, effective, and safe and allows for a higher number of fiducials placed when compared with the traditional backloaded 19-gauge needle., (Copyright © 2021 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)