The Need for Repeat ERCP After Endoscopic Treatment of Postsurgical Biliary Leaks

NCT05141942 | Active Not Recruiting

• 1 other identifier: REB18-2072
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Post-surgical biliary leaks are relatively common after surgeries associated with hepatobiliary health. Left untreated, biliary leaks can lead to significant morbidity. Biliary leaks are most often successfully managed endoscopically, by way of performing an ERCP (endoscopic retrograde cholangio-pancreatography) procedure. These procedures help manage the bile leak by decreasing pressure at the opening of the common bile duct and promoting bile flow into the small bowel (rather than out the leak) via stent insertion. Guidelines published by the American Society for Gastrointestinal Endoscopy (ASGE) report that stents are generally placed for 4 to 6 weeks and recommend longer intervals for more complex leaks. However, formal recommendations concerning the modality of biliary stent removal do not exist. One option is performing a repeat ERCP when removing the stent. While comprehensive, this exposes the patient to additional radiation, and requires additional fluoroscopy resources and/or technicians. Furthermore, ERCPs are less available, especially in smaller centers, and are costly. A second option is a gastroscopy with simple stent removal has, given the low probability of requiring repeat intervention, the relatively low procedural cost, and the relatively favorable adverse event profile, and easier accessibility compared to ERCP procedures. A simple, safe and reliable prediction rule was developed retrospectively to identify patients in whom biliary stent removal via gastroscopy could be safely performed, as opposed to repeat ERCP. A positive result using the rule requires satisfaction of four non-invasive clinical markers: (1) a normal post-surgical serum alkaline phosphatase value, (2) bile leak 'type C' at initial ERCP (a small or absent leak with no other biliary pathology), (3) a bile leak caused by laparoscopic cholecystectomy, and (4) a time between initial and follow-up endoscopy of 4 to 8 weeks. Validating this prediction rule prospectively could have implications on patient safety by decreasing ERCP-related adverse events, and could also have important implications with regard to health resource utilization.

Conditions

Bile Leak

Outcome Measures

Primary Outcomes (1)

• Absence of persistent bile leak

  On repeat endoscopic evaluation absence of persistent bile leak or additional pathology will be evaluated

  immediate

Interventions

Endoscopic Retrograde Cholangiopancreatography (ERCP) PROCEDURE

Endoscopic procedure employed to manage biliary and pancreatic diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients having ERCP for suspected post-surgical biliary leak;

You may qualify if:

• Patients having ERCP for suspected post-surgical biliary leak;
• age 18 years or older
• able to give informed consent to involvement.

You may not qualify if:

• Unable or unwilling to provide informed consent;
• age \< 18 years;
• non-surgical biliary leak;
• previous ERCP with sphincterotomy;
• previous treatment or attempted treatment of biliary leak;
• unsuccessful initial ERCP.

Sponsors & Collaborators

• University of Calgary: lead
• McGill University: collaborator
• Queen's University: collaborator
• Island Health, Victoria, BC: collaborator
• University of Ottawa: collaborator
• Halton Healthcare Oakville: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Nauzer Forbes, MD, MSc

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: November 19, 2019
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: For 5 years after data collection is complete.
• Access Criteria: Access to deidentified aggregate data will be provided upon reasonable request.

Locations

CA (1)