Consensus statements on the current landscape of artificial intelligence applications in endoscopy, addressing roadblocks, and advancing artificial intelligence in gastroenterology.

BACKGROUND AND AIMS: The American Society for Gastrointestinal Endoscopy (ASGE) AI Task Force along with experts in endoscopy, technology space, regulatory authorities, and other medical subspecialties initiated a consensus process that analyzed the current literature, highlighted potential areas, and outlined the necessary research in artificial intelligence (AI) to allow a clearer understanding of AI as it pertains to endoscopy currently. METHODS: A modified Delphi process was used to develop these consensus statements. RESULTS: Statement 1: Current advances in AI allow for the development of AI-based algorithms that can be applied to endoscopy to augment endoscopist performance in detection and characterization of endoscopic lesions. Statement 2: Computer vision-based algorithms provide opportunities to redefine quality metrics in endoscopy using AI, which can be standardized and can reduce subjectivity in reporting quality metrics. Natural language processing-based algorithms can help with the data abstraction needed for reporting current quality metrics in GI endoscopy effortlessly. Statement 3: AI technologies can support smart endoscopy suites, which may help optimize workflows in the endoscopy suite, including automated documentation. Statement 4: Using AI and machine learning helps in predictive modeling, diagnosis, and prognostication. High-quality data with multidimensionality are needed for risk prediction, prognostication of specific clinical conditions, and their outcomes when using machine learning methods. Statement 5: Big data and cloud-based tools can help advance clinical research in gastroenterology. Multimodal data are key to understanding the maximal extent of the disease state and unlocking treatment options. Statement 6: Understanding how to evaluate AI algorithms in the gastroenterology literature and clinical trials is important for gastroenterologists, trainees, and researchers, and hence education efforts by GI societies are needed. Statement 7: Several challenges regarding integrating AI solutions into the clinical practice of endoscopy exist, including understanding the role of human-AI interaction. Transparency, interpretability, and explainability of AI algorithms play a key role in their clinical adoption in GI endoscopy. Developing appropriate AI governance, data procurement, and tools needed for the AI lifecycle are critical for the successful implementation of AI into clinical practice. Statement 8: For payment of AI in endoscopy, a thorough evaluation of the potential value proposition for AI systems may help guide purchasing decisions in endoscopy. Reliable cost-effectiveness studies to guide reimbursement are needed. Statement 9: Relevant clinical outcomes and performance metrics for AI in gastroenterology are currently not well defined. To improve the quality and interpretability of research in the field, steps need to be taken to define these evidence standards. Statement 10: A balanced view of AI technologies and active collaboration between the medical technology industry, computer scientists, gastroenterologists, and researchers are critical for the meaningful advancement of AI in gastroenterology. CONCLUSIONS: The consensus process led by the ASGE AI Task Force and experts from various disciplines has shed light on the potential of AI in endoscopy and gastroenterology. AI-based algorithms have shown promise in augmenting endoscopist performance, redefining quality metrics, optimizing workflows, and aiding in predictive modeling and diagnosis. However, challenges remain in evaluating AI algorithms, ensuring transparency and interpretability, addressing governance and data procurement, determining payment models, defining relevant clinical outcomes, and fostering collaboration between stakeholders. Addressing these challenges while maintaining a balanced perspective is crucial for the meaningful advancement of AI in gastroenterology.

Safety and feasibility of establishing an adjuvant hepatic artery infusion program.

BACKGROUND: Hepatic artery infusion (HAI) is less frequently used in the adjuvant setting for resectable colorectal liver metastasis (CRLM) due to concerns regarding toxicity. Our objective was to evaluate the safety and feasibility of establishing an adjuvant HAI program. METHODS: Patients who underwent HAI pump placement between January 2019 and February 2023 for CRLM were identified. Complications and HAI delivery were compared between patients who received HAI in the unresectable and adjuvant settings. RESULTS: Of 51 patients, 23 received HAI for unresectable CRLM and 28 in the adjuvant setting. Patients with unresectable CRLM more commonly had bilobar disease (n = 23/23 vs n = 18/28, p < 0.01) and more preoperative liver metastases (median 10 [IQR 6-15] vs 4 [IQR 3-7], p < 0.01). Biliary sclerosis was the most common complication (n = 2/23 vs n = 4/28); however, there were no differences in postoperative or HAI-specific complications. In the most recent two years, 0 patients in the unresectable group vs 2 patients in the adjuvant group developed biliary sclerosis. All patients were initiated on HAI with no difference in treatment times or dose reductions. CONCLUSION: Adjuvant HAI is safe and feasible for patients with resectable CRLM. HAI programs can carefully consider including patients with resectable CRLM if managed by an experienced multidisciplinary team with quality assurance controls in place.

The Bethesda ERCP Skills Assessment Tool (BESAT) can reliably differentiate endoscopists of different experience levels.

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.

Effect of an online educational module incorporating real-time feedback on accuracy of polyp sizing in trainees: a randomized controlled trial.

BACKGROUND: Although polyp size dictates surveillance intervals, endoscopists often estimate polyp size inaccurately. We hypothesized that an intervention providing didactic instruction and real-time feedback could significantly improve polyp size classification. METHODS: We conducted a multicenter randomized controlled trial to evaluate the impact of different components of an online educational module on polyp sizing. Participants were randomized to control (no video, no feedback), video only, feedback only, or video + feedback. The primary outcome was accuracy of polyp size classification into clinically relevant categories (diminutive [1-5mm], small [6-9mm], large [≥10mm]). Secondary outcomes included accuracy of exact polyp size (inmm), learning curves, and directionality of inaccuracy (over- vs. underestimation). RESULTS: 36 trainees from five training programs provided 1360 polyp size assessments. The feedback only (80.1%, P=0.01) and video + feedback (78.9%, P=0.02) groups had higher accuracy of polyp size classification compared with controls (71.6%). There was no significant difference in accuracy between the video only group (74.4%) and controls (P=0.42). Groups receiving feedback had higher accuracy of exact polyp size (inmm) and higher peak learning curves. Polyps were more likely to be overestimated than underestimated, and 29.3% of size inaccuracies impacted recommended surveillance intervals. CONCLUSIONS: Our online educational module significantly improved polyp size classification. Real-time feedback appeared to be a critical component in improving accuracy. This scalable and no-cost educational module could significantly decrease under- and overutilization of colonoscopy, improving patient outcomes while increasing colonoscopy access.

Limited exposure to pancreatic ERCP during advanced endoscopy training impacts competence and performance in independent practice.

BACKGROUND/OBJECTIVES: The impact of competency-based training programs on pancreatic endoscopic retrograde cholangiopancreatography (ERCP) performance remains unclear. This study aimed to describe the learning curves of pancreatic ERCP and subsequent performance during independent practice. METHODS: This was a multicenter prospective cohort study involving advanced endoscopy trainees (AETs). In the 1st phase, trainees were assessed on every 5th ERCP using the ERCP and EUS Skills Assessment Tool (TEESAT). Cumulative sum (CUSUM) analysis of pancreatic ERCP evaluations was used to establish learning curves. During the 2nd phase (1st year of independent practice), now-graduated participants documented their performance on key ERCP quality indicators. RESULTS: A total of 24 AETs (20 training programs) received sufficient evaluations for CUSUM analysis. Pancreatic ERCP accounted for 14.6 % (196/1339) of all ERCPs evaluated with 45 % of pancreatic ERCPs carrying a Grade 3 level of complexity. A minority of AETs (16.7 %) performed enough pancreatic ERCPs to generate meaningful learning curves with no AETs achieving competence in pancreatic cannulation, sphincterotomy, or stone clearance during Phase 1. In Phase 2, a total of 3620 ERCPs were performed, of which 281 (7.8 %) were pancreatic ERCPs. While the overall pancreatic duct cannulation rate was 92.2 %, the native papilla pancreatic duct cannulation rate was 85.7 %, which was below the recommended 90 % threshold. CONCLUSIONS: Advanced endoscopy training offers a low level of exposure to pancreatic ERCP, which is mirrored in independent practice, highlighting the inadequate training in pancreatic ERCP. Given the complexity of pancreatic ERCP, novel strategies are warranted to improve training in pancreatic ERCP.

Effect of Polypectomy Simulation-Based Mastery Learning on Skill Retention Among Practicing Endoscopists.

PURPOSE: Practicing endoscopists frequently perform and teach screening colonoscopies and polypectomies, but there is no standardized method to train and assess physicians who perform polypectomy procedures. The authors created a polypectomy simulation-based mastery learning (SBML) curriculum and hypothesized that completion of the curriculum would lead to immediate improvement in polypectomy skills and skill retention at 6 and 12 months after training. METHOD: The authors performed a pretest-posttest cohort study with endoscopists who completed SBML and were randomized to follow-up at 6 or 12 months from May 2021 to August 2022. Participants underwent SBML training, including a pretest, a video lecture, deliberate practice, and a posttest. All learners were required to meet or exceed a minimum passing standard on a 17-item skills checklist before completing training and were randomized to follow-up at 6 or 12 months. The authors compared simulated polypectomy skills performance on the checklist from pretest to posttest and posttest to 6- or 12-month follow-up test. RESULTS: Twenty-four of 30 eligible participants (80.0%) completed the SBML intervention, and 20 of 24 (83.3%) completed follow-up testing. The minimum passing standard was set at 93% of checklist items correct. The pretest passing rate was 4 of 24 participants (16.7%) compared with 24 of 24 participants (100%) at posttest ( P < .001). There were no significant differences in passing rates from posttest to combined 6- and 12-month posttest in which 18 of 20 participants (90.0%) passed. CONCLUSIONS: Before training and despite years of clinical experience, practicing endoscopists demonstrated poor performance of polypectomy skills. SBML was an effective method for practicing endoscopists to acquire and maintain polypectomy skills during a 6- to 12-month period.

Varied Trainee Competence in Cold Snare Polypectomy: Results of the COMPLETE Randomized Controlled Trial.

INTRODUCTION: Cold snare polypectomy (CSP) is strongly recommended as the optimal technique for the complete removal of small polyps. Though significant variability in polypectomy technique and quality has been established, the learning curve and impact of targeted training on CSP are unknown. Video feedback has shown promise as an effective pedagogy to improve performance among surgical trainees. We aimed to compare CSP performance between trainees who received video-based feedback and those who received conventional apprentice-based concurrent feedback. We hypothesized that video-based feedback would accelerate competence. METHODS: We conducted a single-blinded, randomized controlled trial on competence for CSP of polyps <1 cm, comparing video-based feedback with conventional feedback. We randomly assigned deidentified consecutively recorded CSP videos to blinded raters to assess using the CSP Assessment Tool. We shared cumulative sum learning curves every 25 CSP with each trainee. The video feedback trainees also received biweekly individualized terminal feedback. Control trainees received conventional feedback during colonoscopy. The primary outcome was CSP competence. We also assessed competence across domains and change over polypectomy volume. RESULTS: We enrolled and randomized 22 trainees, 12 to video-based feedback and 10 to conventional feedback, and evaluated 2,339 CSP. The learning curve was long; 2 trainees (16.7%) in the video feedback achieved competence, after a mean of 135 polyps, and no one in the control ( P = 0.481) achieved competence. Overall and in all steps of CSP, a higher percentage of the video feedback group met competence, increasing 3% every 20 CSP ( P = 0.0004). DISCUSSION: Video feedback aided trainees to competence in CSP. However, the learning curve was long. Our findings strongly suggest that current training methods are not sufficient to support trainees to competency by the completion of their fellowship programs. The impact of new training methods, such as simulation-based mastery learning, should be assessed to determine whether such methods can result in achievement of competence at a faster rate; ClinicalTrials.gov : NCT03115008.

Esophageal and Esophagogastric Junction Cancers, Version 2.2023, NCCN Clinical Practice Guidelines in Oncology.

Cancers originating in the esophagus or esophagogastric junction constitute a major global health problem. Esophageal cancers are histologically classified as squamous cell carcinoma (SCC) or adenocarcinoma, which differ in their etiology, pathology, tumor location, therapeutics, and prognosis. In contrast to esophageal adenocarcinoma, which usually affects the lower esophagus, esophageal SCC is more likely to localize at or higher than the tracheal bifurcation. Systemic therapy can provide palliation, improved survival, and enhanced quality of life in patients with locally advanced or metastatic disease. The implementation of biomarker testing, especially analysis of HER2 status, microsatellite instability status, and the expression of programmed death-ligand 1, has had a significant impact on clinical practice and patient care. Targeted therapies including trastuzumab, nivolumab, ipilimumab, and pembrolizumab have produced encouraging results in clinical trials for the treatment of patients with locally advanced or metastatic disease. Palliative management, which may include systemic therapy, chemoradiation, and/or best supportive care, is recommended for all patients with unresectable or metastatic cancer. Multidisciplinary team management is essential for all patients with locally advanced esophageal or esophagogastric junction cancers. This selection from the NCCN Guidelines for Esophageal and Esophagogastric Junction Cancers focuses on the management of recurrent or metastatic disease.

Validity evidence for observational ERCP competency assessment tools: a systematic review.

BACKGROUND : Assessment of competence in endoscopic retrograde cholangiopancreatography (ERCP) is critical for supporting learning and documenting attainment of skill. Validity evidence supporting ERCP observational assessment tools has not been systematically evaluated. METHODS : We conducted a systematic search using electronic databases and hand-searching from inception until August 2021 for studies evaluating observational assessment tools of ERCP performance. We used a unified validity framework to characterize validity evidence from five sources: content, response process, internal structure, relations to other variables, and consequences. Each domain was assigned a score of 0-3 (maximum score 15). We assessed educational utility and methodological quality using the Accreditation Council for Graduate Medical Education framework and the Medical Education Research Quality Instrument, respectively. RESULTS : From 2769 records, we included 17 studies evaluating 7 assessment tools. Five tools were studied for clinical ERCP, one for simulated ERCP, and one for simulated and clinical ERCP. Validity evidence scores ranged from 2 to 12. The Bethesda ERCP Skills Assessment Tool (BESAT), ERCP Direct Observation of Procedural Skills Tool (ERCP DOPS), and The Endoscopic Ultrasound (EUS) and ERCP Skills Assessment Tool (TEESAT) had the strongest validity evidence, with scores of 10, 12, and 11, respectively. Regarding educational utility, most tools were easy to use and interpret, and required minimal additional resources. Overall methodological quality (maximum score 13.5) was strong, with scores ranging from 10 to 12.5. CONCLUSIONS : The BESAT, ERCP DOPS, and TEESAT had strong validity evidence compared with other assessments. Integrating tools into training may help drive learners' development and support competency decision making.

Interventions to improve the performance of upper GI endoscopy quality indicators.

The promotion of quality and best practices in gastroenterology and endoscopy is an ongoing effort. For upper GI endoscopy, quality indicators derived from clinical studies and expert consensus have been long established but remain variably obtained. To date, data on interventions aimed to improve these indicators are scarce. We systematically reviewed the literature to identify interventions and measures demonstrated to improve the performance of previously established upper endoscopy quality indicators. We also identified evidence gaps and opportunities for improvement in this area.

Quality Indicators for the Detection and Removal of Colorectal Polyps and Interventions to Improve Them.

Modifiable risk factors for postcolonoscopy colorectal cancer include suboptimal lesion detection (missed neoplasms) and inadequate lesion removal (incomplete polypectomy) during colonoscopy. Competent detection and removal of colorectal polyps are thus fundamental to ensuring adequate colonoscopy quality. Several well-researched quality metrics for polyp detection have been implemented into clinical practice, chief among these the adenoma detection rate. Less data are available on quality indicators for polyp removal, which currently include complete resection rates and skills assessment tools. This review summarizes the available literature on quality indicators for the detection and removal of colorectal polyps, as well as interventions to improve them.

Individualized feedback on colonoscopy skills improves group colonoscopy quality in providers with lower adenoma detection rates.

Background and study aims Colonoscopy inspection quality (CIQ) assesses skills (fold examination, cleaning, and luminal distension) during inspection for polyps and correlates with adenoma detection rate (ADR) and serrated detection rate (SDR). We aimed to determine whether providing individualized CIQ feedback with instructional videos improves quality metrics performance. Methods We prospectively studied 16 colonoscopists who already received semiannual benchmarked reports of quality metrics (ADR, SDR, and withdrawal time [WT]). We randomly selected seven colonoscopies/colonoscopist for evaluation. Six gastroenterologists graded CIQ using an established scale. We created instructional videos demonstrating optimal and poor inspection techniques. Colonoscopists received the instructional videos and benchmarked CIQ performance. We compared ADR, SDR, and WT in the 12 months preceding ("baseline") and following CIQ feedback. Colonoscopists were stratified by baseline ADR into lower (≤ 34 %) and higher-performing (> 34 %) groups. Results Baseline ADR was 38.5 % (range 26.8 %-53.8 %) and SDR was 11.2 % (2.8 %-24.3 %). The proportion of colonoscopies performed by lower-performing colonoscopists was unchanged from baseline to post-CIQ feedback. All colonoscopists reviewed their CIQ report cards. Post-feedback, ADR (40.1 % vs 38.5 %, P  = 0.1) and SDR (12.2 % vs. 11.2 %, P  = 0.1) did not significantly improve; WT significantly increased (11.4 vs 12.4 min, P  < 0.01). Among the eight lower-performing colonoscopists, group ADR (31.1 % vs 34.3 %, P  = 0.02) and SDR (7.2 % vs 9.1 %, P  = 0.02) significantly increased post-feedback. In higher-performing colonoscopists, ADR and SDR did not change. Conclusions CIQ feedback modestly improves ADR and SDR among colonoscopists with lower baseline ADR but has no effect on higher-performing colonoscopists. Individualized feedback on colonoscopy skills could be used to improve polyp detection by lower-performing colonoscopists.

Percutaneous Biliary Neo-anastomosis or Neo-duct Creation Using Radiofrequency Wires.

BACKGROUND AND OBJECTIVE: This study aims to report a minimally invasive, percutaneous technique to cross complete biliary occlusions using a radiofrequency wire to create a biliary-enteric neo-anastomosis or biliary neo-duct. METHODS: All patients who underwent attempted creation of a neo-anastomosis/neo-duct using an RF wire were included in the study. Patients with non-malignant, complete and non-traversable biliary occlusion were considered for the creation of a neo-anastomosis (4 patients)/neo-duct (1 patient). RESULTS: Five patients (4 females, 1 male) with a mean age of 40 years (range: 10-69 years) were included in this study. Percutaneous bowel access was obtained in three of five patients and a snare was placed in the jejunal loop to serve as a target for RF wire advancement. In two patients, an enteral target was provided using a peroral endoscope in collaboration with gastroenterology. The procedure was technically successful in all cases and no intra-operative complications occurred. Patency of the neo-anastomosis was maintained in all patients, with follow-up ranging from 4 to 11 months. CONCLUSION: The RF wire was successfully used to create a biliary neo-anastomosis with a minimally invasive approach for the treatment of non-malignant complete biliary occlusion. This technique offers patients with complete biliary occlusion a safe, effective and durable treatment option which avoids the need for a permanent biliary drain and ultimately results in an improved quality of life.

Gastric Cancer, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology.

Gastric cancer is the third leading cause of cancer-related deaths worldwide. Over 95% of gastric cancers are adenocarcinomas, which are typically classified based on anatomic location and histologic type. Gastric cancer generally carries a poor prognosis because it is often diagnosed at an advanced stage. Systemic therapy can provide palliation, improved survival, and enhanced quality of life in patients with locally advanced or metastatic disease. The implementation of biomarker testing, especially analysis of HER2 status, microsatellite instability (MSI) status, and the expression of programmed death-ligand 1 (PD-L1), has had a significant impact on clinical practice and patient care. Targeted therapies including trastuzumab, nivolumab, and pembrolizumab have produced encouraging results in clinical trials for the treatment of patients with locally advanced or metastatic disease. Palliative management, which may include systemic therapy, chemoradiation, and/or best supportive care, is recommended for all patients with unresectable or metastatic cancer. Multidisciplinary team management is essential for all patients with localized gastric cancer. This selection from the NCCN Guidelines for Gastric Cancer focuses on the management of unresectable locally advanced, recurrent, or metastatic disease.