RecruitingOBSERVATIONAL

Endoscopic Treatment of Post Surgical Biliary Tract Injury

This research is investigating how effective a treatment called endoscopy is for people who have had accidental damage to their bile ducts during an operation. Bile ducts are small tubes that carry bile from the liver. This kind of injury can happen during different types of surgery on the liver or gallbladder, like removing the gallbladder. The study focuses on damage to the main bile ducts, but not a specific duct called the cystic duct or issues after a liver transplant. We want to find out how often this endoscopic treatment successfully fixes the problem and helps people recover.

At a glance

Status

Recruiting

Sponsor

University Hospital, Strasbourg, France

Enrolment target

220

Start

17 Oct 2025

Estimated completion

17 Apr 2027

Biliary Tract Injuries

What is this study about?

Imagine your body has a network of small pipes called bile ducts, which help carry an important liquid called bile from your liver to your gut to help digest food. Sometimes, during surgery on your liver or gallbladder, these delicate pipes can accidentally get nicked or damaged. This can happen during common operations like gallbladder removal (called a cholecystectomy) or other liver surgeries.

This study is looking at a specific way to fix these accidental pipe damages. It uses a procedure called endoscopy, where a thin, flexible tube with a camera is put into your body to see and repair the damage from the inside, often without needing another major operation. The main goal is to see how successful this endoscopic treatment is at repairing these particular types of bile duct injuries.

The researchers are collecting information from people who have had these injuries and were treated with endoscopy. They want to understand how often this treatment works well, helping people get better and preventing further problems. This research is important because it helps doctors learn the best ways to treat these specific surgical complications, potentially improving future care for patients.

Key takeaways

The study explores endoscopic treatment for bile duct injuries after surgery.
It aims to see how successful this treatment is at fixing the damage.
This research looks at existing patient records, so no new involvement is required.
It's for adults (18+) who had specific bile duct injuries during liver or gallbladder surgery.
The findings could help improve future treatments for similar injuries.
Patient privacy and data confidentiality are carefully protected.

Who may be eligible?

To be able to take part in this study, you would need to be an adult, meaning you are 18 years old or older. You must have experienced an injury to one of your main bile ducts or the bile ducts inside your liver during a liver or gallbladder surgery. This could be from an operation done through a large cut or a keyhole surgery.

Your treatment for this injury must have taken place at one of the hospitals involved in this study between January 1, 2021, and December 31, 2024.

However, you wouldn't be able to join if your bile duct injury involved a specific duct called a long cystic duct or if it was related to a gallbladder stump left after a partial removal. Also, if your bile leak happened after a liver transplant, this study would not be the right fit for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Did you have an injury to your main bile duct or bile ducts inside your liver during a gallbladder or liver operation?
Was your treatment for this injury at one of the study hospitals between January 2021 and December 2024?
Was your bile duct injury NOT related to a specific 'cystic duct' or a liver transplant?

Answer every question to see your result.

What does participation involve?

This study is actually looking back at information from patients who have already been treated. This means you wouldn't be asked to do anything new or extra. The researchers will be reviewing the medical records of people who previously had bile duct injuries treated with endoscopy at specific hospitals. There will be no additional visits, assessments, new medications, or follow-up appointments required from you if your information is included in this study. The total 'duration' of your involvement would be the time your past medical records are reviewed by the research team.

Potential risks and benefits

Since this study involves looking at past medical records, there are no direct physical risks to you from participating. Your privacy and the confidentiality of your medical information are protected. A potential benefit of this research is that it helps doctors understand which treatments work best for bile duct injuries, potentially leading to improved care for future patients. While there are no direct benefits to you personally, contributing to medical knowledge is valuable. You always have the right to have your information removed from the study if you change your mind, though since it's historical data, this would be discussed with the research team.

Locations (1)

Service d'Hépato-gastroentérologie - CHU de Strasbourg - France
Verified postcode
Strasbourg, France· Recruiting

Common questions

What are bile ducts?

Bile ducts are small tubes in your body that carry bile, a fluid made by your liver, to help you digest food.

What is 'endoscopy'?

Endoscopy is a procedure where a doctor uses a thin, flexible tube with a tiny camera on the end to look inside your body, and sometimes to fix problems.

Why is this study important?

This study helps doctors learn more about the best ways to fix accidental bile duct injuries that can happen during surgery, aiming to improve care for future patients.

Will I have to do anything if I'm part of this study?

No, this study is looking at past information from medical records, so you won't need to do anything new or have any extra appointments.

Is my personal information kept private?

Yes, all your personal and medical information used in the study is kept confidential and handled with strict privacy measures.

How to find out more

Pierre MAYER, MD

pierre-emmanuel.mayer@chru-strasbourg.fr 33 3.69.55.15.03 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.