Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial).

BACKGROUND & AIMS: Endoscopic ultrasound-guided choledochoduodenostomy with a lumen-apposing metal stent (EUS-CDS) is a promising modality for management of malignant distal biliary obstruction (MDBO) with potential for better stent patency. We compared its outcomes with endoscopic retrograde cholangiopancreatography with metal stenting (ERCP-M). METHODS: In this multicenter randomized controlled trial, we recruited patients with MDBO secondary to borderline resectable, locally advanced, or unresectable peri-ampullary cancers across 10 Canadian institutions and 1 French institution. This was a superiority trial with a noninferiority assessment of technical success. Patients were randomized to EUS-CDS or ERCP-M. The primary end point was the rate of stent dysfunction at 1 year, considering competing risks of death, clinical failure, and surgical resection. Analyses were performed according to intention-to-treat principles. RESULTS: From February 2019 to February 2022, 144 patients were recruited; 73 were randomized to EUS-CDS and 71 were randomized to ERCP-M. The mean (SD) procedure time was 14.0 (11.4) minutes for EUS-CDS and 23.1 (15.6) minutes for ERCP-M (P < .01); 40% of the former was performed without fluoroscopy. Technical success was achieved in 90.4% (95% CI, 81.5% to 95.3%) of EUS-CDS and 83.1% (95% CI, 72.7% to 90.1%) of ERCP-M with a risk difference of 7.3% (95% CI, -4.0% to 18.8%) indicating noninferiority. Stent dysfunction occurred in 9.6% vs 9.9% of EUS-CDS and ERCP-M cases, respectively (P = .96). No differences in adverse events, pancreaticoduodenectomy and oncologic outcomes, or quality of life were noted. CONCLUSIONS: Although not superior in stent function, EUS-CDS is an efficient and safe alternative to ERCP-M in patients with MDBO. These findings provide evidence for greater adoption of EUS-CDS in clinical practice as a complementary and exchangeable first-line modality to ERCP in patients with MDBO. CLINICALTRIALS: gov, Number: NCT03870386.

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.

Outpatient flexible endoscopic diverticulotomy for the management of Zenker's diverticulum: a retrospective analysis of a large single-center cohort.

BACKGROUNDS AND AIMS: Flexible endoscopic Zenker's diverticulotomy (EZD) is well established as a safe and effective technique. Because of rare but concerning adverse events, most centers admit patients for observation and barium swallow study. Our center routinely performs EZD as a day procedure, discharging appropriate patients on the same day after clinical review. This study evaluates outcomes of this cohort compared with previously published studies where patients are admitted for observation. METHODS: A retrospective analysis was performed of EZD procedures done at our center using a flexible endoscope and, in most cases, a diverticulotomy overtube with patients under moderate sedation or general anesthesia. Patients were observed for 2 hours and discharged if no clinical concerns were found. Patient comorbidities, American Society of Anesthesiologists physical status, and endoscopic adverse events were recorded against the American Society for Gastrointestinal Endoscopy severity grading system. RESULTS: Two hundred forty EZD procedures were performed between January 2015 and February 2021. Eleven (4.6%) intraprocedural adverse events occurred: 4 perforations, 4 bleeds, and 1 each postprocedural pain, delirium, and vomiting, respectively. All were recognized within the 2-hour observation period and were managed conservatively, except 1 patient who required surgery. Six patients (2.5%) presented with delayed adverse events: 2 bleeds, 2 perforations, and 2 postprocedural pain. All patients recovered uneventfully with supportive care. CONCLUSIONS: All significant adverse events requiring endoscopic or surgical intervention were identified before discharge. Delayed adverse events occurred in 2.5% of cases, all of which were managed supportively. Our data are comparable with published cohorts of admitted patients, demonstrating that appropriately selected patients may be managed as outpatients while maintaining similar safety outcomes.

Outcomes of Cold Snare Endoscopic Mucosal Resection of Nonampullary Duodenal Adenomas ≥1 cm: A Multicenter Study.

BACKGROUND AND AIMS: Endoscopic mucosal resection (EMR) with use of electrocautery (conventional EMR) has historically been used to remove large duodenal adenomas, however, use of electrocautery can predispose to adverse events including delayed bleeding and perforation. Cold snare EMR (cs-EMR) has been shown to be safe and effective for removal of colon polyps, but data regarding its use in the duodenum is limited. The aim of this study is to evaluate the efficacy and safety of cs-EMR for nonampullary duodenal adenomas ≥1 cm. METHODS: This was a multicenter retrospective study of patients with nonampullary duodenal adenomas ≥1 cm who underwent cs-EMR between October 2014 and May 2023. Patients who received any form of thermal therapy were excluded. Primary outcomes were technical success and rate of recurrent adenoma. Secondary outcomes were adverse events and predictors of recurrence. RESULTS: A total of 125 patients underwent resection of 127 nonampullary duodenal adenomas with cs-EMR. Follow up data was available in 89 cases (70.1%). The recurrent adenoma rate was 31.5% (n=28). Adverse events occurred in 3.9% (n=5) with four cases of immediate bleeding (3.1%) and one case of delayed bleeding (0.8%). There were no cases of perforation. The presence of high-grade dysplasia was found to be an independent predictor of recurrence (OR: 10.9 [95% CI: 1.1-102.1], p=0.036). CONCLUSION: This retrospective multicenter study demonstrates that cs-EMR for nonampullary duodenal adenomas is safe and technically feasible with an acceptable recurrence rate. Future prospective studies are needed to directly compare outcomes of cs-EMR with conventional and underwater EMR.

The Toronto Upper Gastrointestinal Cleaning Score: a prospective validation study.

BACKGROUND : Assessment of mucosal visualization during esophagogastroduodenoscopy (EGD) can be improved with a standardized scoring system. To address this need, we created the Toronto Upper Gastrointestinal Cleaning Score (TUGCS). METHODS : We developed the TUGCS using Delphi methodology, whereby an international group of endoscopy experts iteratively rated their agreement with proposed TUGCS items and anchors on a 5-point Likert scale. After each Delphi round, we analyzed responses and refined the TUGCS using an 80 % agreement threshold for consensus. We used the intraclass correlation coefficient (ICC) to assess inter-rater and test-retest reliability. We assessed internal consistency with Cronbach's alpha and item-total and inter-item correlations with Pearson's correlation coefficient. We compared TUGCS ratings with an independent endoscopist's global rating of mucosal visualization using Spearman's ρ. RESULTS : We achieved consensus with 14 invited participants after three Delphi rounds. Inter-rater reliability was high at 0.79 (95 %CI 0.64-0.88). Test-retest reliability was excellent at 0.83 (95 %CI 0.77-0.87). Cronbach's α was 0.81, item-total correlation range was 0.52-0.70, and inter-item correlation range was 0.38-0.74. There was a positive correlation between TUGCS ratings and a global rating of visualization (r = 0.41, P = 0.002). TUGCS ratings for EGDs with global ratings of excellent were significantly higher than those for EGDs with global ratings of fair (P = 0.01). CONCLUSION : The TUGCS had strong evidence of validity in the clinical setting. The international group of assessors, broad variety of EGD indications, and minimal assessor training improves the potential for dissemination.

Endoscopic full-thickness resection of polyps involving the appendiceal orifice: a multicenter international experience.

BACKGROUND: Endoscopic resection of lesions involving the appendiceal orifice remains a challenge. We aimed to report outcomes with the full-thickness resection device (FTRD) for the resection of appendiceal lesions and identify factors associated with the occurrence of appendicitis. METHODS: This was a retrospective study at 18 tertiary-care centers (USA 12, Canada 1, Europe 5) between November 2016 and August 2020. Consecutive patients who underwent resection of an appendiceal orifice lesion using the FTRD were included. The primary outcome was the rate of R0 resection in neoplastic lesions, defined as negative lateral and deep margins on post-resection histologic evaluation. Secondary outcomes included the rates of: technical success (en bloc resection), clinical success (technical success without need for further surgical intervention), post-resection appendicitis, and polyp recurrence. RESULTS: 66 patients (32 women; mean age 64) underwent resection of colonic lesions involving the appendiceal orifice (mean [standard deviation] size, 14.5 (6.2) mm), with 40 (61 %) being deep, extending into the appendiceal lumen. Technical success was achieved in 59/66 patients (89 %), of which, 56 were found to be neoplastic lesions on post-resection pathology. Clinical success was achieved in 53/66 (80 %). R0 resection was achieved in 52/56 (93 %). Of the 58 patients in whom EFTR was completed who had no prior history of appendectomy, appendicitis was reported in 10 (17 %), with six (60 %) requiring surgical appendectomy. Follow-up colonoscopy was completed in 41 patients, with evidence of recurrence in five (12 %). CONCLUSIONS: The FTRD is a promising non-surgical alternative for resecting appendiceal lesions, but appendicitis occurs in 1/6 cases.

Predictors of recurrence of dysplasia or cancer in patients with dysplastic Barrett's esophagus following complete eradication of dysplasia: a single-center retrospective cohort study.

BACKGROUND AND AIMS: Endoscopic mucosal resection (EMR) and radiofrequency ablation (RFA) for Barrett's esophagus (BE)-related high-grade dysplasia (HGD) and early esophageal adenocarcinoma (EAC) are considered effective treatments for eradication of BE. Little is known about the impact of achieving complete eradication of intestinal metaplasia (CE-IM) following the complete eradication of neoplasia (CE-N), specifically if CE-IM reduces the risk of recurrent dysplasia. METHODS: Retrospective cohort study of consecutive patients with BE and HGD or intramucosal cancer (IMC)-treated endoscopically at a tertiary referral center between 2001 and 2019. Association between CE-IM and recurrent dysplasia after CE-N was evaluated. RESULTS: A total of 433 patients treated with EMR and/or RFA were included. Of these, 381 (88%) achieved CE-N, of which 345 (80%) had adequate follow-up for inclusion in the analysis. A total of 266 (77%) patients achieved CE-IM; with a median follow-up since initial treatment for HGD/IMC of 45.9 months (IQR 25.9, 93.1); 20 patients (5.8%) had recurrent dysplasia after achieving CE-N. Kaplan Meier survival curves revealed that time free of recurrence in those who achieved CE-IM was significantly higher (p = 0.002). In the multivariable analysis, CE-IM was associated with a significant lower hazard of recurrence (HR 0.2, 95% CI 0.1, 0.6), whereas the number of endoscopic treatments to achieve CE-N was associated with a significant higher hazard of recurrence (HR 1.1, 95% CI 1.0, 1.2). CONCLUSION: Achieving CE-IM following CE-N reduces the risk of recurrent dysplasia and should be considered a treatment target among patients with BE undergoing endoscopic therapies for HGD or EAC.

Clinical and pathological predictors of failure of endoscopic therapy for Barrett's related high-grade dysplasia and early esophageal adenocarcinoma.

BACKGROUND AND AIMS: Multimodal endoscopic treatment for Barrett's esophagus (BE) related high-grade dysplasia (HGD) and early esophageal adenocarcinoma (EAC) is safe and effective. However, there is a paucity of data to predict the response to endoscopic treatment. This study aimed to identify predictors of failure to achieve complete eradication of neoplasia (CE-N) and complete eradication of intestinal metaplasia (CE-IM). METHODS: We performed a retrospective analysis of prospectively collected data of all HGD/EAC cases treated endoscopically at a tertiary referral center. Only patients with confirmed HGD/EAC from initial endoscopic mucosal resection (EMR) were included. Potential predictive variables including clinical characteristics, endoscopic features, and index histologic parameters of the EMR specimens were evaluated using multivariate Cox regression. RESULTS: A total of 457 patients were diagnosed with HGD/EAC by initial EMR from January 2008 to January 2019. Of these, 366 patients who underwent subsequent endoscopic treatment with or without RFA were included. Cumulative incidence rates at 3 years for CE-N and CE-IM were 91.4% (95% CI 87.8-94.2%) and 66.8% (95% CI 61.2-72.3%), respectively during a median follow-up period of 35 months. BE segment of 3-10 cm (HR 0.45; 95% CI 0.36-0.57) and > 10 cm (HR 0.25; 95% CI 0.15-0.40) were independent clinical predictors associated with failure to achieve CE-N. With respect to CE-IM, increasing age (HR 0.88; 95% CI 0.78-1.00) was another predictor along with BE segment of 3-10 cm (HR 0.37; 95% CI 0.28-0.49) and > 10 cm (HR 0.15; 95% CI 0.07-0.30). Lymphovascular invasion increased the risk of CE-N and CE-IM failure in EAC cases. CONCLUSION: Failure to achieve CE-N and CE-IM is associated with long-segment BE and other clinical variables. Patients with these predictors should be considered for a more intensive endoscopic treatment approach at expert centers.

Feasibility of adapting the fundamentals of laparoscopic surgery trainer box to endoscopic skills training tool.

BACKGROUND: The fundamentals of laparoscopic surgery (FLS) training box is a validated tool, already accessible to surgical trainees to hone their laparoscopic skills. We aim to investigate the feasibility of adapting the FLS box for the practice and assessment of endoscopic skills. This would allow for a highly available, reusable, low-cost, mechanical trainer. METHODS: The design and development process was based on a user-centered design, which is a combination of the design thinking method and cognitive task analysis. The process comprises four phases: empathy, cognitive, prototyping/adaptation, and end user testing. The underlying idea was to utilize as many of the existing components of FLS training to maintain simplicity and cost effectiveness while allowing for the practice of clinically relevant endoscopic skills. A sample size of 18 participants was calculated to be sufficient to detect performance differences between experts and trainees using a two tailed t test with alpha set at 0.05, standard deviation of 5.5, and a power of 80%. RESULTS: Adaptation to the FLS box included two fundamental attachments: a front panel with an insertion point for an endoscope and a shaft which provides additional support and limits movement of the scope. The panel also allows for mounting of retroflexion tasks. Six endoscopic tasks inspired by FLS were designed (two of which utilize existing FLS components). Pilot testing with 38 participants showed high user's satisfaction and demonstrated that the trainer was robust and reliable. Task performance times was able to discriminate between trainees and experts for all six tasks. CONCLUSIONS: A mechanical, reusable, low-cost adaptation of the FLS training box for endoscopic skills is feasible and has high user satisfaction. Preliminary testing shows that the simulator is able to discriminate between trainees and experts. Following further validation, this adaptation may act as a supplement to the FES program.

Effectiveness and safety of thin vs. thick cold snare polypectomy of small colorectal polyps: Systematic review and meta-analysis.

Background and study aims Cold-snare polypectomy (CSP) is considered the standard of care for resection of colorectal polyps ≤10 mm. Data on the efficacy of CSP performed with thin-wire snares compared0 with thick-wire snares are conflicting. We performed a meta-analysis comparing complete resection (CR) and adverse event rates of CSP using thin-wire and thick-wire snares. Patients and methods Comparative studies of adult patients with ≧1 colorectal polyp(s) ≦10 mm who underwent CSP with thin-wire or thick-wire snares were included. We collected data on study, patient, polyp, and snare characteristics. The primary outcome was CR rate. Secondary outcomes were polyp retrieval rate, intraprocedural bleeding, delayed post-polypectomy bleeding, deep mural injury or perforation, patient discomfort, total sedation, and procedure time. We used random-effects models to calculate risk ratios for outcomes. We performed risk of bias assessments, rated the certainty of evidence, and assessed publication bias for all studies. Results We included four randomized controlled trials (RCTs) and two observational studies including 1316 patients with 1679 polyps (826 thin-wire CSPs and 853 thick-wire CSPs). There was no significant difference between thin-wire CSP (92.1%) and thick-wire CSP (87.7%) for RCTs (risk ratio [RR] 1.05, 95% confidence interval [CI] 0.94-1.16) or observational studies (78.1% versus 79.6%, RR 1.03, 95% CI 0.99-1.08). There were no significant differences in polyp retrieval rate or intraprocedural bleeding. There were no cases of delayed bleeding or perforation. Conclusions We found no differences in CR rates for CSP between thin-wire and thick-wire snares. CSP, regardless of snare type, is safe and effective for resection of small colorectal polyps.

A new through-the-scope clip with anchor prongs is safe and successful for a variety of endoscopic uses.

Background and study aims Endoscopic through-the-scope clips (TTSC) are used for hemostasis and closure. We documented the performance of a new TTSC with anchor prongs. Patients and methods We conducted a prospective case series of the new TTSC in 50 patients with an indication for endoscopic clipping at three hospitals in the United States and Canada. Patients were followed for 30 days after the index procedure. Outcomes included defect closure and rate of serious adverse events (SAEs) related to the device or procedure. Results Fifty patients had 56 clipping procedures. Thirty-four procedures were clipping after endoscopic mucosal resection (EMR) in the colon (33) or stomach (1), 16 after polypectomy, two for hemostasis of active bleeding, and one each for fistula closure, per-oral endoscopic myotomy mucosal closure, or anchoring a feeding tube. Complete defect closure was achieved in 32 of 33 colon EMR defects and 21 of 22 other defects. All clips were placed per labeled directions for use. In 41 patients (82.0%), prophylaxis of delayed bleeding was reported as an indication for endoscopic clipping. There were three instances of delayed bleeding. There were no device-related SAEs. The only technical difficulty was one instance of premature clip deployment. Conclusions A novel TTSC with anchor prongs showed success in a range of defect closures, an acceptable safety profile, and low incidence of technical difficulties.

Unified Magnifying Endoscopic Classification (UMEC) of Gastrointestinal Lesions: A North American Validation Study.

Background and study aim: Magnifying endoscopy enables the diagnosis of advanced neoplasia throughout the gastrointestinal tract. The unified magnifying endoscopic classification (UMEC) framework unifies optical diagnosis criteria in the esophagus, stomach, and colon, dividing lesions into three categories: non-neoplastic, intramucosal neoplasia, and deep submucosal invasive cancer. This study aims to ascertain the performance of North American endoscopists when using the UMEC. Methods: In this retrospective cohort study, five North American endoscopists without prior training in magnifying endoscopy independently diagnosed images of gastrointestinal tract lesions using UMEC. All endoscopists were blinded to endoscopic findings and histopathological diagnosis. Using histopathology as the gold standard, the endoscopists' diagnostic performances using UMEC were evaluated. Results: A total of 299 lesions (77 esophagus, 92 stomach, and 130 colon) were assessed. For esophageal squamous cell carcinoma, the sensitivity, specificity, and accuracy ranged from 65.2% (95%CI: 50.9-77.9) to 87.0% (95%CI: 75.3-94.6), 77.4% (95%CI: 60.9-89.6) to 96.8% (95%CI: 86.8-99.8), and 75.3% to 87.0%, respectively. For gastric adenocarcinoma, the sensitivity, specificity, and accuracy ranged from 94.9% (95%CI: 85.0-99.1) to 100%, 52.9% (95%CI: 39.4-66.2) to 92.2% (95%CI: 82.7-97.5), and 73.3% to 93.3%. For colorectal adenocarcinoma, the sensitivity, specificity, and accuracy ranged from 76.2% (95%CI: 62.0-87.3) to 83.3% (95%CI: 70.3-92.5), 89.7% (95%CI: 82.1-94.9) to 97.7% (95%CI: 93.1-99.6), and 86.8% to 90.7%. Intraclass correlation coefficients indicated good to excellent reliability. Conclusion: UMEC is a simple classification that may be used to introduce endoscopists to magnifying narrow-band imaging and optical diagnosis, yielding satisfactory diagnostic accuracy.

A Nationwide Survey of Training Pathways and Practice Trends of Endoscopic Submucosal Dissection in Canada.

Background: Endoscopic submucosal dissection (ESD) has become an established standard for endoscopic removal of large gastrointestinal (GI) lesions and early GI malignancies. However, ESD is technically challenging and requires significant health care infrastructure. As such, its adoption in Canada has been relatively slow. The practice of ESD across Canada remains unclear. Our study aimed to provide a descriptive overview of training pathways and practice trends of ESD in Canada. Methods: Current ESD practitioners across Canada were identified and invited to participate in an anonymous cross-sectional survey. Results: Twenty-seven ESD practitioners were identified; survey response rate was 74%. Respondents were from 15 different institutions. All practitioners underwent international ESD training of some type. Fifty per cent pursued long-term ESD training programs. Ninety-five per cent attended short-term training courses. Sixty per cent and 40% performed hands-on live human upper and lower GI ESD, respectively, before independent practice. In practice, 70% saw an increase per year in number of procedures performed from 2015 to 2019. Sixty per cent were dissatisfied with their institution's health care infrastructure to support ESD. Thirty-five per cent perceived their institution as supportive of expanding the practice of ESD. Conclusions: Several challenges exist to the adoption of ESD in Canada. Training pathways are variable, with no set standards. In practice, practitioners express dissatisfaction with access to necessary infrastructure and feel poorly supported in expanding the practice of ESD. As ESD is increasingly the accepted standard for the treatment of many neoplastic GI lesions, greater collaboration between practitioners and institutions is crucial to standardize training and ensure patient access.

Impact of Residing in Below Median Household Income Districts on Outcomes in Patients with Advanced Barrett's Esophagus.

Background: Barrett's esophagus (BE) is a premalignant condition to esophageal adenocarcinoma (EAC). Low socioeconomic (SES) status adversely impacts care and outcomes in patients with EAC, but this has not been evaluated in BE. As the treatment of BE is similarly intensive, we aimed to evaluate the effect of SES on achieving complete eradication of intestinal metaplasia (CE-IM), dysplasia (CE-D) and development of invasive EAC. Methods: Our study was a retrospective cohort study. Consecutive patients between January 1, 2010, to December 31, 2018, referred for BE-associated high-grade dysplasia or intramucosal adenocarcinoma were included. Pre, intra and post-procedural data were collected. Household income data was collected from the 2016 census based on postal code region. Patients were divided into income groups relative to the 2016 median household income in Ontario. Multivariate regression was performed for outcomes of interest. Results: Four hundred and fifty-nine patients were included. Rate of CE-IM was similar between income groups. Fifty-five per cent (n = 144/264) versus 65% (n = 48/264) in the below and above-income groups achieved CE-D, respectively, P = 0.02. Eighteen per cent (n = 48/264) versus 11% (n = 22/195) were found to have invasive EAC during their treatment course in below and above-income groups, respectively, P = 0.04. Residing in a below-median-income district was associated with developing invasive EAC (Odds Ratio, [OR] 1.84, 95% confidence interval [CI] 1.01 to 3.35) and failure to achieve CE-D (OR 0.64, 95% CI 0.42 to 0.97). Conclusions: Residing in low-income districts is associated with worse outcomes in patients with advanced BE. Further research is needed to guide future initiatives to address the potential impact of SES barriers in the optimal care of BE.