Incidence, Predictors, and Outcomes of Clinically Significant Post-ERCP Bleeding: a Contemporary Multi-center Study.

BACKGROUND AIMS: Clinically significant post-endoscopic retrograde cholangiopancreatography (ERCP) bleeding (CSPEB) is common. Contemporary estimates of risk are lacking. We aimed to identify risk factors for and outcomes following CSPEB. METHODS: We analyzed multi-center prospective ERCP data between 2018-2023 with 30-day follow-up. The primary outcome was CSPEB, defined as hematemesis, melena, or hematochezia resulting in: hemoglobin drop ≥20 g/L or transfusion and/or endoscopy to evaluate suspected bleeding, and/or unplanned healthcare visitation and/or prolongation of existing admission. Firth logistic regression was employed. P-values <0.05 were significant, with odds ratios (ORs) and 95% confidence intervals reported. RESULTS: CSPEB occurred following 129 (1.5%) of 8,517 ERCPs (mean onset 3.2 days), with 110 of 4,849 events (2.3%) occurring following higher-risk interventions (sphincterotomy, sphincteroplasty, pre-cut sphincterotomy, and/or needle-knife access). CSPEB patients required endoscopy and transfusion in 86.0% and 53.5% of cases, respectively, with three cases (2.3%) being fatal. P2Y12 inhibitors were held for a median of 4 days (IQR 4) prior to higher-risk ERCP. Following higher-risk interventions, P2Y12 inhibitors (OR 3.33, 1.26-7.74), warfarin (OR 8.54, 3.32-19.81), dabigatran (OR 13.40, 2.06-59.96), rivaroxaban (OR 7.42, 3.43-15.24) and apixaban (OR 4.16, 1.99-8.20) were associated with CSPEB. Significant intraprocedural bleeding post sphincterotomy (OR 2.32, 1.06-4.60), but not post sphincteroplasty, was also associated. Concomitant cardiorespiratory events occurred more frequently within 30 days following CSPEB (OR 12.71, 4.75-32.54). CONCLUSIONS: Risks of antiplatelet-related CSPEB may be underestimated by endoscopists based on observations of suboptimal holding before higher-risk ERCP. Appropriate periprocedural antithrombotic management is essential and could represent novel quality initiative targets.

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.

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.

Development of American Society for Gastrointestinal Endoscopy standards for training in advanced endoscopy within dedicated advanced endoscopy fellowship programs.

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.

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.

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.

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.

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.

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.

AGA Clinical Practice Update on Strategies to Improve Quality of Screening and Surveillance Colonoscopy: Expert Review.

The purpose of this American Gastroenterological Association Institute Clinical Practice Update was to review the available evidence and provide best practice advice regarding strategies to improve the quality of screening and surveillance colonoscopy. This review is framed around 15 best practice advice statements regarding colonoscopy quality that were agreed upon by the authors, based on a review of the available evidence and published guidelines. This is not a formal systematic review and thus no formal rating of the quality of evidence or strength of recommendation has been carried out.

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.

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.

Pancreatic Cystic Lesions and Malignancy: Assessment, Guidelines, and the Field Defect.

The widespread use of high-spatial-resolution cross-sectional imaging has led to an increase in detection of incidental pancreatic cystic lesions. These lesions are a diverse group, ranging from indolent and premalignant lesions to invasive cancers. The diagnosis of several of these lesions can be suggested on the basis of their imaging appearance, while many other lesions require follow-up imaging and/or aspiration. The smaller cystic lesions, often branch-duct intraductal papillary mucinous neoplasms, have overlapping imaging characteristics that make diagnostic assessment of the natural history and malignancy risk confusing. Expert panels have developed societal guidelines, based on a consensus, for surveillance of these lesions. However, these guidelines are often inconsistent and are constantly evolving as additional scientific data are accumulated. Identification of features associated with increased risk of malignancy is important for proper management. The concept of field defect, whereby pancreatic adenocarcinoma develops at a site different from the site of the pancreatic cyst, adds to the complexity of screening guidelines. As a result of the differences in guidelines, key stakeholders (eg, radiologists, gastroenterologists, and surgeons) must review and come to a consensus regarding which guideline, or combination of guidelines, to follow at their individual institutions. Standardized reporting and macros are helpful for ensuring the uniformity of interpretations. Radiologists play a critical role in the detection and characterization of pancreatic cystic lesions, in the follow-up recommendations for these lesions, and in the detection of associated cancer. An invited commentary by Zaheer is available online. Online supplemental material is available for this article. ©RSNA, 2021.

Bariatric Bypass Surgery Is a Risk Factor for Incomplete Colonoscopy Preparation.

OBJECTIVES: Effective colon cancer screening requires adequate bowel preparation. Anecdotal evidence has suggested that patients with a history of bariatric surgery are more likely to have inadequate preparation. This study aims to evaluate the role of bariatric surgery as a predictive risk factor for inadequate bowel preparation. METHODS: Data were collected retrospectively for consecutive colonoscopies between March 1, 2013, and November 15, 2017. Only the index colonoscopy for each patient within the review period, and those scored using the Boston Bowel Preparation Scale (BBPS) were included. Inadequate preparation was defined as any one or more colon segments with a BBPS score of less than two, and patients with a history of bariatric surgery were identified using ICD 9/10 codes. Multivariate logistic regression and propensity score matching was used to assess for independent factors predictive of inadequate bowel preparation. RESULTS: A total of 25,318 colonoscopies were included in the analysis. Two hundred 278 (1.1%) patients had a history of bariatric surgery, among which 171 (61.5%) had a history of bypass surgery and 107 (38.5%) had a history of restrictive surgical procedure. A history of bariatric surgery was predictive of inadequate bowel preparation in both univariate (OR: 2.87, 95% CI: 1.92-4.29, P = 0.0003) and multivariate analysis (OR: 2.16, 95% CI: 1.43-3.27, P = 0.0003) after controlling for differences in baseline characteristics. When evaluated separately, a history of bypass surgery was associated with inadequate bowel preparation (aOR: 2.96, 95% CI: 1.86-4.72, P < 0.0001), whereas a history of a restrictive bariatric surgery was not associated with inadequate bowel preparation in multivariate analysis (aOR: 0.98, 95% CI: 0.4-2.45, P = 0.971). CONCLUSIONS: A history of bariatric surgery is an independent risk factor for inadequate bowel preparation. Furthermore, bypass bariatric surgeries had higher rates of inadequate preparation when compared to restrictive bariatric surgeries. Further quality improvement initiatives should be directed at identifying the appropriate bowel preparation regimen in this population.

The quality of screening colonoscopy in rural and underserved areas.

BACKGROUND: Screening colonoscopy effectiveness depends on procedure quality; however, knowledge about colonoscopy quality in rural and underserved areas is limited. This study aimed to describe the characteristics and quality of colonoscopy and to examine predictors of colonoscopy quality at rural and underserved hospitals. METHODS: Adults undergoing colonoscopy from April 2017 to March 2019 at rural or underserved hospitals across the Illinois Surgical Quality Improvement Collaborative were prospectively identified. The primary outcome was colorectal adenoma detection, and secondary outcomes included bowel preparation adequacy, cecum photodocumentation, and withdrawal time. Performance was benchmarked against multisociety guidelines, and multivariable logistic regression was used to examine patient, physician, and procedure characteristics associated with adenoma detection. RESULTS: In total, 4217 colonoscopy procedures were performed at 8 hospitals, including 1865 screening examinations performed by 19 surgeons, 9 gastroenterologists, and 2 family practitioners. Physician screening volume ranged from 2 to 218 procedures (median 50; IQR 23-74). Adenoma detection occurred in 26.6% of screening procedures (target: ≥ 25%), 90.7% had adequate bowel preparation (target: ≥ 85%), 93.1% had cecum photodocumentation (target: ≥ 95%), and mean withdrawal time was 8.1 min (target: ≥ 6). Physician specialty was associated with adenoma detection (gastroenterologists: 36.9% vs. surgeons: 22.5%; OR 2.30, 95% CI 1.40-3.77), but adequate bowel preparation (OR 1.15, 95% CI 0.76-1.73) and cecum photodocumentation (OR 1.56, 95% CI 0.91-2.69) were not. CONCLUSION: Colonoscopies performed at rural and underserved hospitals meet many quality metrics; however, quality varied widely. As physicians are scarce in rural and underserved areas, individualized interventions to improve colonoscopy quality are needed.

An Unsuccessful Randomized Trial of Percutaneous vs Endoscopic Drainage of Suspected Malignant Hilar Obstruction.

Percutaneous transhepatic biliary drainage (PTBD) and endoscopic retrograde cholangiopancreatography (ERCP) are widely accepted but competing approaches for the management of malignant obstruction at the hilum of the liver. ERCP is favored in the United States on the basis of high success rates for non-hilar indications, the perceived safety and superior tissue sampling capability of ERCP relative to PTBD, and the avoidance of external drains that are undesirable to patients. A recent randomized controlled trial (RCT) comparing the 2 modalities in patients with resectable hilar cholangiocarcinoma was terminated prematurely because of higher mortality in the PTBD group.1 In contrast, most observational data suggest that PTBD is superior for achieving complete drainage.2-6 Because the preferred procedure remains uncertain, we aimed to compare PTBD and ERCP as the primary intervention in patients with cholestasis due to malignant hilar obstruction (MHO).

Development and validation of a patient-reported scale for tolerability of endoscopic procedures using conscious sedation.

BACKGROUND AND AIMS: Patient-reported experience measures (PREMs) assessing the tolerability of endoscopic procedures are scarce. In this study, we designed and validated a PREM to assess tolerability of endoscopy using conscious sedation. METHODS: The patient-reported scale for tolerability of endoscopic procedures (PRO-STEP) consists of questions within 2 domains and is administered to outpatients at discharge from the endoscopy unit. Domain 1 (intraprocedural) consists of 2 questions regarding discomfort/pain and awareness, whereas domain 2 (postprocedural) consists of 4 questions on pain, nausea, distention, and either throat or anal pain. All questions are scored on a Likert scale from 0 to 10. Cronbach's alpha was used to measure internal consistency of the questions. Multivariable logistic regression was performed to assess predictors of higher scores, reported using adjusted odds ratios and confidence intervals. RESULTS: Two hundred fifty-five patients (91 colonoscopy, 73 gastroscopy, and 91 ERCP) were included. Colonoscopy was the least tolerable procedure by recall, with mean intraprocedural awareness and discomfort scores of 5.1 ± 3.8, and 2.6 ± 2.7, respectively. Consistency between intraprocedural awareness and discomfort/pain yielded an acceptable Cronbach's alpha of .71 (95% confidence interval, .62-.78). Higher use of midazolam during colonoscopy was inversely associated with an intraprocedural awareness score of 7 or higher (per additional mg: adjusted odds ratio, .23; 95% confidence interval, .09-.54). CONCLUSIONS: PRO-STEP is a simple PREM that can be administered after multiple endoscopic procedures using conscious sedation. Future work should focus on its performance characteristics in adverse event prediction.

Cecal retroflexion is infrequently performed in routine practice and the retroflexed view is of poor quality.

BACKGROUND: As right colon polyps are challenging to detect, a retroflexed view of right colon (RV) may be useful. However, cecal retroflexion (CR) without a RV to the hepatic flexure (HF) is inadequate. We aimed to determine the frequency of CR and quality of the RV in routine practice. METHODS: This prospective observational study performed at an academic medical center assessed colonoscopy inspection technique of endoscopists who had performed ≥ 100 annual screening colonoscopies. We video recorded ≥ 28 screening/surveillance colonoscopies per endoscopist and randomly evaluated 7 videos per endoscopist. Six gastroenterologists blindly reviewed the videos to determine if CR was performed and HF withdrawal time (cecum to HF time, excluding ileal/polypectomy time). RESULTS: Reviewers assessed 119 colonoscopies performed by 17 endoscopists. The median HF withdrawal time was 3 min and 46 s. CR was performed in 31% of colonoscopies. CR frequency varied between endoscopists with 9 never performing CR and 2 performing CR in all colonoscopies. When performed, nearly half (43%) of RVs did not extend to the HF with median RV duration of 16 s (IQR 9-30 s). Three polyps were identified in the RV (polyp detection rate of 8.1%), all identified prior to a forward view. CONCLUSIONS: CR is performed infrequently in routine practice. When CR is performed, the RV is of low quality with a very short inspection duration and insufficient ascending colon examination. Further education is required to educate endoscopists in optimal technique to improve overall colonoscopy quality.

Adoption of Multi-society Guidelines Facilitates Value-Based Reduction in Screening and Surveillance Colonoscopy Volume During COVID-19 Pandemic.

BACKGROUND: COVID-19 has caused a backlog of endoscopic procedures; colonoscopy must now be prioritized to those who would benefit most. We determined the proportion of screening and surveillance colonoscopies appropriate for rescheduling to a future year through strict adoption of US Multi-Society Task Force (USMSTF) guidelines. METHODS: We conducted a single-center observational study of patients scheduled for "open-access colonoscopy"-ordered by a primary care provider without being seen in gastroenterology clinic-over a 6-week period during the COVID-19 pandemic. Each chart was reviewed to appropriately assign a surveillance year per USMSTF guidelines including demographics, colonoscopy history and family history. When guidelines recommended a range of colonoscopy intervals, both a "conservative" and "liberal" guideline adherence were assessed. RESULTS: We delayed 769 "open-access" screening or surveillance colonoscopies due to COVID-19. Between 14.8% (conservative) and 20.7% (liberal), colonoscopies were appropriate for rescheduling to a future year. Conversely, 415 (54.0%) patients were overdue for colonoscopy. Family history of CRC was associated with being scheduled too early for both screening (OR 3.9; CI 1.9-8.2) and surveillance colonoscopy (OR 2.6, CI 1.0-6.5). The most common reasons a colonoscopy was inappropriately scheduled this year were failure to use new surveillance colonoscopy intervals (28.9%), incorrectly applied family history guidelines (27.2%) and recommending early surveillance colonoscopy after recent normal colonoscopy (19.3%). CONCLUSION: Up to one-fifth of patients scheduled for "open-access" colonoscopy can be rescheduled into a future year based on USMSTF guidelines. Rigorously applying guidelines could judiciously allocate colonoscopy resources as we recover from the COVID-19 pandemic.

Morphology of the major papilla predicts ERCP procedural outcomes and adverse events.

BACKGROUND: The morphology of the major papilla affects the difficulty of endoscopic retrograde cholangiopancreatography (ERCP), but no associations with adverse events have previously been established. We aimed to assess whether papillary morphology predicts ERCP adverse events. METHODS: A retrospective analysis was performed of a prospective registry of patients undergoing ERCP for biliary indications. The primary outcome was post-ERCP pancreatitis (PEP), with secondary outcomes including other adverse events and procedural outcomes such as inadvertent pancreatic duct cannulation, cannulation time, and attempts. Papillae were classified as normal (Type I), small or flat (Type II), bulging (Type IIIa), pendulous (Type IIIb), creased (Type IV), or peri-diverticular (Type D). Outcomes were ascertained prospectively at 30 days from index procedures. RESULTS: A total of 637 patients with native papillae were included. Compared to Type I papillae, Type II and Type IIIb papillae were associated with PEP, with adjusted odds ratios (AOR) of 7.28 (95% confidence intervals, CI, 1.84-28.74) and 4.25 (95% CI 1.26-14.32), respectively. Type II and IIIb papillae were associated with significantly longer cannulation times by 5.37 (95% CI 2.39-8.35) and 4.01 (95% CI 1.72-6.30) minutes, respectively. Type IIIb papillae were associated with lower deep cannulation success (AOR 0.17, 95% CI 0.06-0.48). CONCLUSION: Papillary morphology is an important factor influencing both ERCP success and outcomes. Understanding this is key for managing intraprocedural approaches and minimizing adverse events. PROSPECTIVE REGISTRY REGISTRATION: Clinicaltrials.gov identifier NCT04259580.