Characteristics and Outcomes of ERCP at a Canadian Tertiary Centre: Initial Results from a Prospective High-Fidelity Biliary Endoscopy Registry

Abstract

Background Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure in the management of pancreatic and biliary disease. While its role is firmly established, further well-designed prospective ERCP research is required, as a large portion of previous work has employed retrospective or administrative methodologies, both prone to potential biases. The aim of the Calgary Registry for Advanced and Therapeutic Endoscopy (CReATE) is to be a high-fidelity prospective multicentre registry. Methods The study population consisted of consecutive adult ERCP patients from September 2018 to September 2019. Informed consent was acquired for each patient. All relevant preprocedural, procedural, peri-procedural and postprocedural data were captured in real time by a full-time third-party research assistant directly observing procedures. Outcomes were ascertained by comprehensive medical record review and patient phone interview 30 days after the index procedure. Results Five endoscopists performed 895 ERCP procedures, 90.1% of which were deemed successful. Suspected choledocholithiasis was the most common indication for ERCP, followed by suspected or confirmed stricture(s), at 61.0% and 29.5%, respectively. 61.0% of procedures were performed on ERCP-naive patients. Post-ERCP pancreatitis occurred following 4.9% of procedures, with clinically significant bleeding or perforation occurring following 1.8% and 0.1% of procedures, respectively. Discussion Through 12 months, CReATE captured 895 procedures prospectively, with each entry containing over 300 data fields. Active expansion to additional tertiary centres is underway, and this will enhance the existing data pool. CReATE has the potential to improve multiple facets of ERCP, including training, optimal procedural techniques, mitigation of adverse events and personalized patient care.

Canadian Association of Gastroenterology (CAG) Position Statement on the Use of Hyoscine-n-butylbromide (Buscopan) During Gastrointestinal Endoscopy

“…It should be noted that currently, Buscopan is commonly used during ERCP when peristalsis is interfering with successful cannulation, given that cannulation-related adverse events are well-established ( 26 , 27 ). Thus, most conservative and relatively low-cost interventions are frequently employed if there is direct or indirect evidence they can serve to mitigate these AEs.…”

Test Performance Characteristics of Dynamic Liver Enzyme Trends in the Prediction of Choledocholithiasis

“…Similarly, between 2012 and 2018, practice patterns could have conceivably changed between the start and end of our timeframe. We plan on assessing the test performance characteristics of dynamic enzyme changes prospectively using prospective data from 2018 onward [ 16 ], at which time potential temporal changes in practice will also be assessed. Fourthly, we opted to include cases in which either sludge and/or stones were found in the biliary tree, but one must recognize that dynamic enzyme trends could perform differently if only stones were considered positive findings.…”

“…All procedures in the study were performed by one of six endoscopists, each having performed over 1000 of the respective procedures, or by trainees under their direct supervision. More than 60% of ERCPs were performed for indications of suspected CDL [ 16 ]. This study was approved by our institutional research ethics board (REB18-1053).…”

Consensus-based development of a causal attribution system for post-ERCP adverse events

“…The next step in this process is the validation of our system using real-world data composed of actual AEs from a large data set of ERCP procedures 7. In order to maximise usability, we plan to validate the performance characteristics of our system within several assessor groups such as (1) a panel of endoscopists, (2) individual endoscopists and (3) research assistants, similar to our recent study that validated a similar causal attribution for post-colonoscopy bleeding 8…”