Recruiting NCT07345936
Endoscopic Treatment of Post Surgical Biliary Tract Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Biliary Tract Injuries. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The objective of this study is to determine the technical and clinical success rate of endoscopic treatment in a population presenting only with iatrogenic injuries of the bile ducts, excluding the cystic duct.
Primary outcome measures
- Clinical success rate of the initial endoscopic procedure [Time frame: Immediately after surgery]
- Clinical success rate at 3 months after the end of treatment [Time frame: 3 months after the end of treatment]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
France · 1 center
- Service d'Hépato-gastroentérologie - CHU de Strasbourg - France — Strasbourg
Identifiers
NCT: NCT07345936 · 9943