Endoscopic repair of bile duct injuries after surgery
Official title: Endoscopic Treatment of Post Surgical Biliary Tract Injury
Run by University Hospital, Strasbourg, France · NCT07345936 · Data updated 2026-11-12
This project will try endoscopic methods to fix bile duct injuries that happen during hepatobiliary surgery in adults, excluding injuries of the cystic duct.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | October 17, 2025 |
| Main results expected | April 2027 |
| Study ends | April 17, 2027 |
| Registry record updated | January 16, 2026 |
| Trial ID | NCT07345936 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) who sustained iatrogenic injuries to the common bile duct or intrahepatic bile ducts after hepatobiliary surgery and were treated at one of the participating centers between January 1, 2021 and December 31, 2024.
✕Probably not a fit
Patients with biliary wounds occurring on a long cystic duct or gallbladder stump and those with bile leaks after liver transplantation are excluded and therefore will not be included in or benefit from this analysis.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational cohort at CHU de Strasbourg including adults treated between January 1, 2021 and December 31, 2024 for iatrogenic injuries of the common or intrahepatic bile ducts after hepatobiliary surgery. The study will collect details of the endoscopic approaches used (for example ERCP with stenting or dilation), procedural success, clinical outcomes, and complications. Patients with injuries limited to a long cystic duct or gallbladder stump and those after liver transplantation are excluded. The goal is to report real-world technical and clinical success rates of endoscopic management in this specific population.
Why it matters
Potential benefit: If successful, it could show that many post-surgical bile duct injuries can be managed with endoscopy, reducing the need for more invasive surgery and its risks.
How similar studies have gone: Previous case series and cohort reports indicate that endoscopic management (such as ERCP with stenting or dilation) often achieves high technical and clinical success for many iatrogenic bile duct leaks and strictures, though complex transections frequently still require surgery.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (≥18 years old) * Subject who has had a wound of the common bile duct or intrahepatic bile ducts following hepatobiliary surgery (laparotomy or laparoscopic cholecystectomy or major or minor hepatectomy) * Subject treated in one of the associated centers between January 1, 2021, and December 31, 2024 Exclusion Criteria: * Biliary wound occurring on a long cystic duct or gallbladder stump during partial cholecystectomy. * Biliary leakage complicating liver transplantation
Where it's running
-
Service d'Hépato-gastroentérologie - CHU de Strasbourg - France
Strasbourg, France Recruiting
Study contacts
- Study coordinator: Pierre MAYER, MD
- Email: pierre-emmanuel.mayer@chru-strasbourg.fr
- Phone: 33 3.69.55.15.03
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.