Establishment of Standards for the Referral of Large Non-Pedunculated Colorectal Polyps: An International Expert Consensus Using a Modified Delphi Process.

BACKGROUND AND AIMS: Resection of colorectal polyps has been shown to decrease the incidence and mortality of colorectal cancer. Large non-pedunculated colorectal polyps are often referred to expert centres for endoscopic resection, which requires relevant information to be conveyed to the therapeutic endoscopist to allow for triage and planning of resection technique. The primary objective of our study was to establish minimum expected standards for the referral of LNPCP for potential ER. METHODS: A Delphi methodology was employed to establish consensus on minimum expected standards for the referral of large colorectal polyps among a panel of international endoscopy experts. The expert panel was recruited through purposive sampling, and three rounds of surveys were conducted to achieve consensus, with quantitative and qualitative data analysed for each round. RESULTS: A total of 24 international experts from diverse continents participated in the Delphi study, resulting in consensus on 19 statements related to the referral of large colorectal polyps. The identified factors, including patient demographics, relevant medications, lesion factors, photodocumentation and the presence of a tattoo, were deemed important for conveying the necessary information to therapeutic endoscopists. The mean scores for the statements ranged from 7.04 to 9.29 out of 10, with high percentages of experts considering most statements as a very high priority. Subgroup analysis by continent revealed some variations in consensus rates among experts from different regions. CONCLUSION: The identified consensus statements can aid in improving the triage and planning of resection techniques for large colorectal polyps, ultimately contributing to the reduction of colorectal cancer incidence and mortality.

Gender authorship in major American and European gastroenterology journals: the gap is still unfilled.

BACKGROUND: The gender gap in the authorship of scientific research may affect career advancement. Our aim was to assess the potential gender gap in gastrointestinal (GI) journals. METHODS: A systematic review was performed of the GI literature and ongoing research in the period 2020-2022. A total 10 GI journals and ongoing research on clinicaltrials.gov were selected for review. The gender gap in first and senior authorship was evaluated for each article and ongoing research project. Associations between the gender gap and possible predictors were measured and results are presented as odds ratios (ORs) with 95%CI. RESULTS: The number of first female authors (FFAs) and senior female authors (SFAs) in published articles were 1408/4207 (33.5%) and 911/4207 (21.7%), respectively. There were 781/2654 (29.4%) female principal investigators (PI)s for the ongoing research. On comparison of non-endoscopic vs. endoscopic topics, the latter were associated with the gender gap (hepatology, OR 2.15 [95%CI 1.83-2.55]; inflammatory bowel disease, OR 2.12 [95%CI 1.60-2.45]; upper and lower GI, OR 1.31 [95%CI 1.18-1.73]); as well as the type of article (original article vs. editorial, OR 1.92 [95%CI 1.58-2.33]). The type of research was also associated with the gender gap (clinical vs. preclinical studies, OR 0.88 [95%CI 0.66-0.91]). CONCLUSION: Our results demonstrated a correlation between the gender gap and the design and topic of the research. Future strategies for improving equity in career development in GI endoscopy should focus on closing the gender gap in equity of authorship.

Peroral endoscopic myotomy for spastic esophageal dysmotility among opioid users: a multicenter propensity score matching study.

BACKGROUND AND AIMS: Opioid-induced esophageal dysfunction (OIED) often presents as spastic esophageal disorders (SEDs) and esophagogastric junction outflow obstruction (EGJOO). The aim of this study was to evaluate and compare clinical outcomes of peroral endoscopic myotomy (POEM) for SEDs and EGJOO among opioid users and nonusers. METHODS: This propensity score (PS) matching study included consecutive opioid users and nonusers who underwent POEM for SEDs and EGJOO between January 2018 and September 2022. The following covariates were used for the PS calculation: age, sex, duration of symptoms, Eckardt score, type of motility disorder, and length of myotomy during POEM. Clinical response was defined as a post-POEM Eckardt score ≤3. RESULTS: A total of 277 consecutive patients underwent POEM during the study period. PS matching resulted in the selection of 64 pairs of patients strictly matched 1:1 (n = 128) with no statistically significant differences in demographic, baseline, or procedural characteristics or in the parameters considered for the PS between the 2 groups. Clinical response to POEM was significantly lower among opioid users (51 of 64 [79.7%]) versus nonusers (60 of 64 [93.8%]) (P = .03) at a median follow-up of 18 months. Among opioid users, higher opioid dose (>60 morphine milligram equivalents per day) was associated with a higher likelihood of failure to respond to POEM (odds ratio, 4.59; 95% confidence interval, 1.31-3.98; P = .02). CONCLUSIONS: Clinical response to POEM for SEDs and EGJOO is significantly lower among opioid users versus nonusers. There was a dose-relationship between opioids and response to POEM, with higher daily opioid usage associated with a higher likelihood of treatment failure.

Utility of Intraprocedural Luminal Diameter and Distensibility Measurements During the Esophageal Peroral Endoscopic Myotomy Procedure.

GOALS: Through evaluation of the lower esophageal sphincter immediately before and after myotomy using an endoluminal functional lumen imaging probe (EFLIP), our study aimed to determine the clinical response to peroral endoscopic myotomy (POEM) and the incidence of postprocedure reflux. BACKGROUND: Achalasia is a rare esophageal motility disorder characterized by impaired relaxation of the lower esophageal sphincter (LES) and diminished peristalsis. POEM is a therapeutic option for durable management of achalasia. However, symptomatic acid reflux and esophagitis are well-known adverse effects of the procedure. STUDY: Electronic medical records of 168 patients who underwent POEM for achalasia at 2 tertiary care referral centers from May 2014 to May 2021 were reviewed. EFLIP was used at a range of catheter fill volumes to assess LES dynamics. Preprocedure and postprocedure Eckardt Symptom Scores were recorded. RESULTS: Significant clinical improvement from POEM was sustained in over 94% of patients after 1 year. EFLIP changed intraprocedural management 5% of the time by means of myotomy extension. In patients with reflux>1 year following POEM, there was no significant difference in post-POEM LES diameter or change in LES diameter compared with those without reflux. However, post-POEM LES distensibility index (DI) was significantly higher in patients with reflux after 1 year compared with those without reflux. CONCLUSIONS: POEM is a safe and increasingly effective therapy for patients with symptomatic achalasia. Intraprocedural EFLIP measurements suggest that post-POEM reflux may be correlated more with DI than LES diameter. Yet, more data is needed to substantiate these outcomes.

Use of a Novel Artificial Intelligence System Leads to the Detection of Significantly Higher Number of Adenomas During Screening and Surveillance Colonoscopy: Results From a Large, Prospective, US Multicenter, Randomized Clinical Trial.

INTRODUCTION: Adenoma per colonoscopy (APC) has recently been proposed as a quality measure for colonoscopy. We evaluated the impact of a novel artificial intelligence (AI) system, compared with standard high-definition colonoscopy, for APC measurement. METHODS: This was a US-based, multicenter, prospective randomized trial examining a novel AI detection system (EW10-EC02) that enables a real-time colorectal polyp detection enabled with the colonoscope (CAD-EYE). Eligible average-risk subjects (45 years or older) undergoing screening or surveillance colonoscopy were randomized to undergo either CAD-EYE-assisted colonoscopy (CAC) or conventional colonoscopy (CC). Modified intention-to-treat analysis was performed for all patients who completed colonoscopy with the primary outcome of APC. Secondary outcomes included positive predictive value (total number of adenomas divided by total polyps removed) and adenoma detection rate. RESULTS: In modified intention-to-treat analysis, of 1,031 subjects (age: 59.1 ± 9.8 years; 49.9% male), 510 underwent CAC vs 523 underwent CC with no significant differences in age, gender, ethnicity, or colonoscopy indication between the 2 groups. CAC led to a significantly higher APC compared with CC: 0.99 ± 1.6 vs 0.85 ± 1.5, P = 0.02, incidence rate ratio 1.17 (1.03-1.33, P = 0.02) with no significant difference in the withdrawal time: 11.28 ± 4.59 minutes vs 10.8 ± 4.81 minutes; P = 0.11 between the 2 groups. Difference in positive predictive value of a polyp being an adenoma among CAC and CC was less than 10% threshold established: 48.6% vs 54%, 95% CI -9.56% to -1.48%. There were no significant differences in adenoma detection rate (46.9% vs 42.8%), advanced adenoma (6.5% vs 6.3%), sessile serrated lesion detection rate (12.9% vs 10.1%), and polyp detection rate (63.9% vs 59.3%) between the 2 groups. There was a higher polyp per colonoscopy with CAC compared with CC: 1.68 ± 2.1 vs 1.33 ± 1.8 (incidence rate ratio 1.27; 1.15-1.4; P < 0.01). DISCUSSION: Use of a novel AI detection system showed to a significantly higher number of adenomas per colonoscopy compared with conventional high-definition colonoscopy without any increase in colonoscopy withdrawal time, thus supporting the use of AI-assisted colonoscopy to improve colonoscopy quality ( ClinicalTrials.gov NCT04979962).

Development and initial validation of a video-based peroral endoscopic myotomy assessment tool.

BACKGROUND AND AIMS: Video analysis has emerged as a potential strategy for performance assessment and improvement. We aimed to develop a video-based skill assessment tool for peroral endoscopic myotomy (POEM). METHODS: POEM was deconstructed into basic procedural components through video analysis by an expert panel. A modified Delphi approach and 2 validation exercises were conducted to refine the POEM assessment tool (POEMAT). Twelve assessors used the final POEMAT version to grade 10 videos. Fully crossed generalizability (G) studies investigated the contributions of assessors, endoscopists' performance, and technical elements to reliability. G coefficients below .5 were considered unreliable, between .5 and .7 as modestly reliable, and above .7 as indicative of satisfactory reliability. RESULTS: After task deconstruction, discussions, and the modified Delphi process, the final POEMAT comprised 9 technical elements. G analysis showed low variance for endoscopist performance (.8%-24.9%) and high interrater variability (range, 63.2%-90.1%). The G score was moderately reliable (≥.60) for "submucosal tunneling" and "myotomy" and satisfactorily reliable (≥.70) for "active hemostasis" and "mucosal closure." CONCLUSIONS: We developed and established initial content and response process validity evidence for the POEMAT. Future steps include appraisal of the tool using a wider range of POEM videos to establish and improve the discriminative validity of this tool.

Chemotherapy and Immune Checkpoint Blockade for Gastric and Gastroesophageal Junction Adenocarcinoma.

Importance: Combining immune checkpoint blockade (ICB) with chemotherapy improves outcomes in patients with metastatic gastric and gastroesophageal junction (G/GEJ) adenocarcinoma; however, whether this combination has activity in the perioperative setting remains unknown. Objective: To evaluate the safety and preliminary activity of perioperative chemotherapy and ICB followed by maintenance ICB in resectable G/GEJ adenocarcinoma. Design, Setting, and Participants: This investigator-initiated, multicenter, open-label, single-stage, phase 2 nonrandomized controlled trial screened 49 patients and enrolled 36 patients with resectable G/GEJ adenocarcinoma from February 10, 2017, to June 17, 2021, with a median (range) follow-up of 35.2 (17.4-73.0) months. Thirty-four patients were deemed evaluable for efficacy analysis, with 28 (82.4%) undergoing curative resection. This study was performed at 4 referral institutions in the US. Interventions: Patients received 3 cycles of capecitabine, 625 mg/m2, orally twice daily for 21 days; oxaliplatin, 130 mg/m2, intravenously and pembrolizumab, 200 mg, intravenously with optional epirubicin, 50 mg/m2, every 3 weeks before and after surgery with an additional cycle of pembrolizumab before surgery. Patients received 14 additional doses of maintenance pembrolizumab. Main Outcomes and Measures: The primary end point was pathologic complete response (pCR) rate. Secondary end points included overall response rate, disease-free survival (DFS), overall survival (OS), and safety. Results: A total of 34 patients (median [range] age, 65.5 [25-90] years; 23 [67.6%] male) were evaluable for efficacy. Of these patients, 28 (82.4%) underwent curative resection, 7 (20.6%; 95% CI, 10.1%-100%) achieved pCR, and 6 (17.6%) achieved a pathologic near-complete response. Of the 28 patients who underwent resection, 4 (14.3%) experienced disease recurrence. The median DFS and OS were not reached. The 2-year DFS was 67.8% (95% CI, 0.53%-0.87%) and the OS was 80.6% (95% CI, 0.68%-0.96%). Treatment-related grade 3 or higher adverse events for evaluable patients occurred in 20 patients (57.1%), and 12 (34.3%) experienced immune-related grade 3 or higher adverse events. Conclusion and Relevance: In this trial of unselected patients with resectable G/GEJ adenocarcinoma, capecitabine, oxaliplatin, and pembrolizumab resulted in a pCR rate of 20.6% and was well tolerated. This trial met its primary end point and supports the development of checkpoint inhibition in combination with perioperative chemotherapy in locally advanced G/GEJ adenocarcinoma. Trial Registration: ClinicalTrials.gov Identifier: NCT02918162.

Predictors of success of conventional ERCP for bile duct stones and need for single-operator cholangioscopy.

Background and study aims The characteristics of difficult stones requiring cholangioscopy-assisted lithotripsy are poorly defined. We sought to determine clinician perception of these characteristics and decision-making in biliary endoscopy. Methods One hundred twenty-four delegates attending an online course were invited to assess 20 clinical stone cases. Each image was graded on a 4-point Likert for: grading of stone difficulty, confidence of clearance with conventional endoscopic retrograde cholangiopancreatography (ERCP) methods, likelihood of needing cholangioscopy-assisted lithotripsy, and confidence of clearance with one session of lithotripsy. An independent reviewer rated each case on largest stone size, stone number, presence of stricture distal to stone, size of stone relative to distal duct size, and acute common bile duct (CBD) angulation < 135°. Multilevel (mixed) statistical methods with a two-level model were utilized with multilevel ordinal logistic regression. Results Stone size and location, stricture and stone diameter:duct ratio impacted perceived procedural difficulty P < 0.01). Stone:duct ratio (< 50% odds ratio [OR] 0.22, P < 0.001), stricture (OR 7.26, P < 0.001) and stone location impacted confidence of clearance with conventional ERCP. Intrahepatic and cystic duct stones were least likely to engender confidence ( P < 0.01). The same factors plus CBD angulation < 135° predicted cholangioscopy requirement ( P < 0.01). Stone number did not influence procedure difficulty or cholangioscopy requirement. Strictures (OR 0.29, P < 0.001) and location, especially intrahepatic (OR 0.42, P < 0.001) impaired confidence in clearance with one cholangioscopy session. Conclusions Ductal anatomy, the presence of a stricture distal to a stone, cystic and intrahepatic stones and stones larger than the distal duct are considered by endoscopists to be significant predictors of requiring cholangioscopy-assisted lithotripsy.

Accuracy in Polyp Size Measurement Among Surgeons, Gastroenterologists, Trainees, and Experts: A Prospective Video-Based Study.

INTRODUCTION: Polyp size determination plays an important role in endoscopic decision making and follow-up determination. However, there is a lack of knowledge of endoscopist accuracy for polyp sizing and efficacy of available tools for size measurement. Our aim was to compare the accuracy of visual assessment, snare, forceps, and virtual scale endoscope (VSE) in estimating polyp size among a diverse group of endoscopists. METHODS: We conducted a prospective video-based study. One hundred twenty polyps measured and recorded along with all available measurement tools were randomized to visual assessment, snare, forceps, or VSE group. Eleven endoscopists conducted video-based measurement using the randomized measurement tool. Primary outcome was relative accuracy in polyp size measurement compared with caliper measurement immediately postresection. RESULTS: One thousand three hundred twenty measurements were performed. VSE had statistically significantly higher relative accuracy when compared to forceps (79.3 vs 71.3%; P < 0.0001). Forceps had statistically significantly higher relative accuracy when compared to visual assessment (71.3 vs 63.6%; P = 0.0036). There was no statistically significant difference when comparing visual assessment and snare-based measurements (63.6 vs 62.8%; P = 0.797). Overall, 21.5% of polyps >5 mm were misclassified as ≤5 mm and 17.3% of polyps ≥10 mm were misclassified as <10 mm. VSE had the lowest percentage of polyps >5 mm misclassified as ≤5 mm (2.6%), polyps ≤5 mm misclassified as >5 mm (5.1%), and polyps <10 mm misclassified as ≥10 mm (1.7%). DISCUSSION: Visual size estimation of polyps is inaccurate independently of training level, sex, and specialty. Size measurement accuracy can be improved using forceps and yields the highest relative accuracy when an adaptive scale technology is used.

Endoscopic Ultrasound-Guided Biliary Drainage.

Endoscopic retrograde cholangiopancreatography (ERCP) and percutaneous transhepatic biliary drainage (PTBD) are currently first- and second-line therapeutic options, respectively, for the relief of biliary obstruction. In recent years, however, endoscopic ultrasound-guided biliary drainage (EUS-BD) has become an established alternative therapy for biliary obstruction. There are multiple different techniques for EUS-BD, which can be distinguished based on the access point within the biliary tree (intrahepatic versus extrahepatic) and the location of stent placement (transenteric versus transpapillary). The clinical and technical success rates of biliary drainage for EUS-BD are similar to both ERCP and PTBD, and complication rates are favorable for EUS-BD relative to PTBD. As EUS-BD becomes more widely practiced and endoscopic tools continue to advance, the outcomes will likely improve, and the breadth of indications for EUS-BD will continue to expand.

Endoscopic Submucosal Dissection Facilitating Techniques Among Non-experts: A Systematic Literature Review.

BACKGROUND AND AIMS: The dissemination of endoscopic submucosal dissection (ESD) has been limited by its technical complexity and safety profile, particularly among non-experts. Various techniques and devices have facilitated the performance of ESD, but their yield and role in the path to learning ESD remain unclear. METHODS: We performed a systematic review by querying MEDLINE, EMBASE, Web of Science, and Japan Medical Abstracts Society specifically for comparative studies investigating the impact of assigned ESD techniques vs. conventional techniques among non-experts in ESD (< 50 ESD procedures). Procedural outcomes of efficacy, efficiency, and safety were assessed. RESULTS: We identified 46 studies evaluating 54 cohorts in which a total 237 non-experts performed 2461 ESDs conventionally, and 1953 ESDs using an assigned ESD technique (knives, countertraction, miscellaneous techniques). The majority of studies were from East Asia (67%), single-center (96%), observational in design (61%), in an animal model (57%), and gastric location (63%). The most studied techniques were countertraction techniques (48% cohorts) and scissor knives (15% cohorts), both of which commonly enhanced efficiency of ESD, and less so efficacy or safety. Techniques found to be beneficial in experts were more likely to be beneficial in non-experts (70% concordance) than vice versa (47% concordance). CONCLUSION: Based on the currently available literature, countertraction techniques and scissor knives should be considered for early incorporation into ESD training by non-experts. Several aspects of ESD training remain understudied, including techniques in Western non-experts, educational resources, and several commonly cited techniques. These areas should guide future investigation to enhance the pathway to learning ESD.

Management of Adults With Esophageal Atresia.

Esophageal atresia (EA) with or without trachea-esophageal fistula is relatively common congenital malformation with most patients living into adulthood. As a result, care of the adult patient with EA is becoming more common. Although surgical repair has changed EA from a fatal to a livable condition, the residual effects of the anomaly may lead to a lifetime of complications. These include effects related to the underlying deformity such as atonicity of the esophageal segment, fistula recurrence, and esophageal cancer to complications of the surgery including anastomotic stricture, gastroesophageal reflux, and coping with an organ transposition. This review discusses the occurrence and management of these conditions in adulthood and the role of an effective transition from pediatric to adult care to optimize adult care treatment.

AGA Clinical Practice Update on Management of Subepithelial Lesions Encountered During Routine Endoscopy: Expert Review.

BEST PRACTICE ADVICE STATEMENTS: BEST PRACTICE ADVICE 1: Forceps bite-on-bite or deep-well biopsies or tunnel biopsies can sometimes establish a pathologic diagnosis of SEL. BEST PRACTICE ADVICE 2: EUS is the modality of choice to evaluate indeterminate SEL of the GI track and/or if non-diagnostic tissue by forceps biopsies. BEST PRACTICE ADVICE 3: SEL arising from the submucosa can be sampled using tunnel biopsies (or deep-well biopsies), EUS guided fine-needle aspiration (FNA), EUS guided fine-needle biopsy (FNB), or advanced endoscopic techniques (unroofing or endoscopic submucosal resection). BEST PRACTICE ADVICE 4: SEL arising from muscularis propria should be sampled (preferably using FNB or FNA) to determine whether the lesion is a GIST or leiomyoma. Structural assessment and staining will allow differentiation of mesenchymal tumors and assessing their malignant potential. BEST PRACTICE ADVICE 5: Endoscopic resection techniques have been described for removal of SEL and should be limited to endoscopists skilled in advanced tissue resection techniques. BEST PRACTICE ADVICE 6: Management of each SEL depends on the size of the lesion, histopathology, their malignant potential, and presence of symptoms. BEST PRACTICE ADVICE 7: SEL that have an endoscopic appearance consistent with a lipoma or pancreatic rest and normal mucosal biopsies do not need further evaluation or surveillance. BEST PRACTICE ADVICE 8: For SEL arising from muscularis propria that are less than 2 cm in size, surveillance using EUS should be considered. BEST PRACTICE ADVICE 9: Gastric GIST larger than 2 cm should be considered for resection. BEST PRACTICE ADVICE 10: Subepithelial lesions that are ulcerated, bleeding, or causing symptoms should be considered for resection.

Rare Complication of Endoscopic Variceal Therapy: Wide-Complex Tachycardia Associated With Embolization of Glue and Coil.

We present the case of a woman with upper gastrointestinal bleeding secondary to gastric varices requiring endoscopic cyanoacrylate glue and coil embolization. The procedure was complicated by regular, wide-complex tachycardia, with further investigation revealing cardiopulmonary migration of the glue and coil. (Level of Difficulty: Advanced.).