Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial.

INTRODUCTION: Symptoms, endoscopy and histology have been proposed as therapeutic targets in ulcerative colitis (UC). Observational studies suggest that the achievement of histologic remission may be associated with a lower risk of complications, compared with the achievement of endoscopic remission alone. The actiVE ulcerative colitis, a RanDomIsed Controlled Trial (VERDICT) aims to determine the optimal treatment target in patients with UC. METHODS AND ANALYSIS: In this multicentre, prospective randomised study, 660 patients with moderate to severe UC (Mayo rectal bleeding subscore [RBS] ≥1; Mayo endoscopic score [MES] ≥2) are randomly assigned to three treatment targets: corticosteroid-free symptomatic remission (Mayo RBS=0) (group 1); corticosteroid-free endoscopic remission (MES ≤1) and symptomatic remission (group 2); or corticosteroid-free histologic remission (Geboes score <2B.0), endoscopic remission and symptomatic remission (group 3). Treatment is escalated using vedolizumab according to a treatment algorithm that is dependent on the patient's baseline UC therapy until the target is achieved at weeks 16, 32 or 48. The primary outcome, the time from target achievement to a UC-related complication, will be compared between groups 1 and 3 using a Cox proportional hazards model. ETHICS AND DISSEMINATION: The study was approved by ethics committees at the country level or at individual sites as per individual country requirements. A full list of ethics committees is available on request. Study results will be disseminated in peer-reviewed journals and at scientific meetings. TRIAL REGISTRATION NUMBER: EudraCT: 2019-002485-12; NCT04259138.

Post-ERCP cholecystitis: Incidence, characteristics, and outcomes from a prospective multicenter biliary endoscopy registry.

BACKGROUND AND AIMS: The incidence, risk factors, and outcomes of post-ERCP cholecystitis are poorly described. We aimed to describe cases of post-ERCP cholecystitis from a prospective multicenter registry with protocolized 30-day follow-up. METHODS: Patient- and procedure-related data from 7 centers were obtained. The primary outcome was post-ERCP cholecystitis, defined according to a Delphi-based criteria and causal attribution system. Risk factors and outcomes were described for all cases. RESULTS: Seventeen cases of post-ERCP cholecystitis were identified among 4428 patients with gallbladders undergoing ERCP between 2018 and 2023 (incidence, 0.38%; 95% confidence interval, 0.20-0.57). In ERCPs with covered metal stenting, 7 of 467 resulted in cholecystitis (incidence, 1.50%; 95% confidence interval, 0.40-2.60). Patients had symptoms at a median of 5 days (interquartile range, 5) after ERCP. Management strategies included cholecystectomy, percutaneous cholecystostomy, and endoscopic stent removal/exchange. CONCLUSIONS: Estimates of post-ERCP cholecystitis incidence can inform discussions around procedural risk.

Standard reporting elements for the performance of EUS: Recommendations from the FOCUS working group.

BACKGROUND AND OBJECTIVES: Quality indicators for the performance of EUS have been developed to monitor and improve service value and patient outcomes. To support the incorporation of these indicators and standardize EUS documentation, we propose standard EUS reporting elements for endosonographers and endoscopy units. METHODS: A comprehensive literature search and review was performed to identify EUS quality indicators and key components of high-quality standardized EUS reporting. Guidance statements regarding standard EUS reporting elements were developed and reviewed at the Forum for Canadian Endoscopic Ultrasound (FOCUS) 2019 Annual Meeting. RESULTS: EUS reporting elements can be divided into preprocedural, intraprocedural, and postprocedural items. Preprocedural components include the type, indication, and urgency of the procedure and patient clinical information and consent. Intraprocedural components include the adequacy and extent of examination, relevant landmarks, lesion characteristics, sampling method, specimen quality, and intraprocedural adverse events. Postprocedural components include a summary and synthesis of relevant findings as well as recommended management and follow-up. CONCLUSIONS: Standardizing reporting elements may help improve the care of patients undergoing EUS procedures. Our review provides a practical guide and compilation of recommended reporting elements to ensure ongoing best practices and quality improvement in EUS.

A proposal for the ideal algorithm for the diagnosis, staging, and treatment of pancreas masses suspicious for pancreatic adenocarcinoma: Results of a working group of the Canadian Society for Endoscopic Ultrasound.

Numerous clinical pathways exist for patients presenting with a suspicious pancreatic mass. These range from direct surgical intervention following staging, with preoperative cross-sectional imaging, EUS with or without fine-needle aspiration or fine-needle core biopsy; neoadjuvant chemotherapy and/or radiation therapy; or palliation. Although international guidelines exist for pancreas cancer management, the ideal workup and treatment for a suspicious pancreas mass is unclear. During its annual meeting in September 2017 (The Forum for Canadian Endoscopic Ultrasonography), the Canadian Society of Endoscopic Ultrasound organized a working group of experienced endosonographers and hepatobiliary surgeons from across Canada to achieve this goal.

Accuracy of endoscopic ultrasound-fine needle aspiration of solid lesions over time: Experience from a new endoscopic ultrasound program at a Canadian community hospital.

BACKGROUND AND OBJECTIVES: A Canadian Community Hospital launched a new Endoscopic Ultrasound (EUS) Program in 2011. The aim of this study was to report the accuracy of EUS-fine needle aspiration (EUS-FNA) of solid lesions over time as it pertains to cytotechnologists' involvement and learning curves. METHODS: The electronic medical records of patients that had a EUS from July 2011 to January 2014 were retrospectively reviewed. Only solid lesions with FNA sampling were included in the study. The primary outcome assessed was the accuracy of specimen acquisition for pathological review. The secondary outcome was diagnostic accuracy. Cases were separated by chronological order into thirds for the assessment of learning curves. Cytotechnologists' involvement was correlated to determine its impact on accuracy. RESULTS: Two hundred and seventy-one EUS-FNA procedures were completed for solid lesions. Cytotechnologists' involvement resulted in a specimen acquisition accuracy of 82.6%, compared with 68.8% without a cytotechnologist (P = 0.009; 95% confidence interval [CI] 3.2%-25.0%). Diagnostic accuracy was 74.2% with a cytotechnologist while 62.4% without a cytotechnologist (P = 0.038; 95% CI 0.3%-23.7%). The specimen acquisition accuracy increased from 73.2% from the first third of cases to 92.3% for the last third with a cytotechnologist (P = 0.004; 95% CI 6%-33.0%). Without a cytotechnologist, the specimen accuracy was 67.6% for the first third while 57.7% for the last third of cases (P = 0.434; 95% CI - 33.9-14.4%). In the multivariable regression analysis, after adjusting for other predictors, a present cytotechnologist (P = 0.022) and lesion size 21 mm-30 mm (P = 0.039) and >30 mm (P = 0.001) were significantly associated with increased specimen acquisition accuracy. Only a present cytotechnologist (P = 0.046) was significantly associated with increased diagnostic accuracy. INTERPRETATION: Cytotechnologists' involvement significantly improved the accuracy of specimen acquisition. Although accuracy was impacted by a cytotechnologist learning curve, our results highlight the importance of a cytotechnologist being present for EUS-FNA sampling of solid lesions.

Community experience of colonic stenting in patients with acute large bowel obstructions.

BACKGROUND: Self-expandable metal stents (SEMS) can provide temporary relief of acute large bowel obstructions. Placement of SEMS creates the opportunity for semi-elective 1-stage surgical resections, use of possible adjuvant therapy or palliative relief of malignant obstructions. Our aim was to assess the likelihood of success and possible complication rates of SEMS insertion in a community hospital setting in patients presenting with large bowel obstructions. METHODS: We conducted a retrospective chart review at a single community-based hospital. This review addressed the technical success in deployment of the SEMS, clinical success defined by relief of the obstruction, procedure-related complications, surgical interventions and completion of adjuvant therapy for patients with large bowel obstructions. RESULTS: In a 34-month period, 16 patients underwent 16 SEMS procedures. The average age of patients was 69.4 years and 7 (44%) were women. Thirteen patients had intrinsic colorectal cancers, 1 had an extracolonic lesion (ovarian cancer) and 2 had strictures due to diverticular disease. Technical success occurred in all 16 patients, but only 15 (94%) had clinical success. No procedure-related deaths (defined as death within 7 days) occurred. Palliative stenting occurred in 5 patients (31%). Eleven patients (69%) eventually had surgery. Stenting allowed a window for neoadjuvant therapy in 4 patients. Ten of 11 patients (91%) had a 1-stage procedure. One patient had a cecal perforation presenting 2 days after SEMS. This patient received a defunctioning ileostomy. CONCLUSION: In appropriate patients with large bowel obstructions, SEMS proced ures can be safely and effectively performed in a community-based setting.

The quality of screening colonoscopies in an office-based endoscopy clinic.

BACKGROUND: Wait times for hospital screening colonoscopy have increased dramatically in recent years, resulting in an increase in patient referrals to office-based endoscopy clinics. There is no formal regulation of office endoscopy, and it has been suggested that the quality of service in some office locations may be inferior to hospital procedures. OBJECTIVE: To compare the quality of office-based screening colonoscopies at a clinic in Oakville, Ontario, with published benchmarks for cecal intubation, withdrawal times, polyp detection, adenoma detection, cancer detection and patient complications. METHODS: Demographic information on consecutive patients and colonoscopy reports by all nine gastroenterologists at the Oakville Endoscopy Centre between August 2006 and December 2007 were prospectively obtained. RESULTS: A total of 3741 colonoscopies were analyzed. The mean age of patients was 57.1 years and 51.9% were women. The cecal intubation rate was 98.98% with an average withdrawal time of 9.75 min. A total of 3857 polyps were retrieved from 1725 patients (46.11%), and 1721 adenomas were detected in 953 patients (25.47%). A total of 126 patients (3.37%) had advanced polyps and 18 (0.48%) were diagnosed with colon cancer. One patient (0.027%) had a colonic perforation and two patients had postpolypectomy bleeding (0.053%). These results meet or exceed published benchmarks for quality colonoscopy. CONCLUSIONS: The Ontario Endoscopy Centre data demonstrate that office-based colonoscopies, performed by well-trained physicians using adequate sedation and hospital-grade equipment, result in outcomes at least equal to or better than those of published academic/community hospital practices and are therefore a viable option for the future of screening colonoscopy in Canada.

Electrohydraulic lithotripsy in 111 patients: a safe and effective therapy for difficult bile duct stones.

BACKGROUND: Choledocholithiasis and intrahepatic bile duct stones pose a significant health hazard, especially in the elderly. The large stone not removable with conventional endoscopic techniques, can be effectively and safely managed with electrohydraulic lithotripsy (EHL). METHODS: This study is a retrospective review of consecutive patients at the Wellesley Central Hospital and St. Michael's Hospital, who underwent peroral endoscopic fragmentation of bile duct stones with EHL under direct cholangioscopic control using a "mother-baby" endoscopic system between October 1990 and March 2002. RESULTS: To date, 111 patients have been analyzed. Of the 111 patients reviewed, 94 patients have had complete records and were included in this study. Mean follow-up was 26.2 months (range 0-80). Prior to EHL, 93 of 94 patients (99%) had endoscopic retrograde cholangiopancreatography (ERCP) and failed standard stone extraction techniques (mean 1.9 ERCPs/patient, range 0-5). Indications for EHL were large stones (81 patients) or a narrow caliber bile duct below a stone of average size (13 patients). Successful fragmentation (61 complete, 28 partial) was achieved in 89 of 93 patients (96%) (1 patient was excluded from analysis due to a broken endoscope). Fragmentation failures were due to targeting problems (2 patients) and hard stones (2 patients). Seventy-six percent of patients required 1 EHL session, 14% required 2 sessions, and 10% required 3 or more. All patients with successful stone fragmentation required post-EHL balloon or basket extraction of fragments. Complications included: cholangitis and/or jaundice (13 patients); mild hemobilia (1 patient); mild post-ERCP pancreatitis (1 patient); biliary leak (1 patient); and bradycardia (1 patient). There were no deaths related to EHL. Final stone clearance was achieved in 85 of 94 patients (90%). CONCLUSIONS: EHL via peroral endoscopic choledochoscopy is a highly successful and safe technique for use in the management of difficult choledocholithiasis and intrahepatic stones. This study has shown a stone fragmentation rate of 96% (89 of 93 patients), and a final stone clearance rate of 90% (85 of 94 patients).

Endoscopic Management of Lower Gastrointestinal Bleeding.

Colonoscopy continues to be the primary tool for diagnostic evaluation and management of lower gastrointestinal bleeding (LGIB). With the advent of newer endoscopy delivery therapeutic modalities, the treatment of LGIB has changed dramatically over the decades. The most dramatic change has been the role of surgery, which has been substantially reduced due to the therapeutic colonoscopy. This article reviews recent advances in the endoscopic treatment options in LGIB of the colon and rectum.