Biliary Tract InjuriesEpSBNCT07345936
Endoscopic Treatment of Post Surgical Biliary Tract Injury
An observational study of Biliary Tract Injuries, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Injuries
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2025to 17 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient 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)
Who may be able to join
- 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
Who cannot join
- Biliary wound occurring on a long cystic duct or gallbladder stump during partial cholecystectomy.
- Biliary leakage complicating liver transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'Hépato-gastroentérologie - CHU de Strasbourg - France
Strasbourg, 67091
Pierre MAYER, MD, 33 3.69.55.15.03, pierre-emmanuel.mayer@chru-strasbourg.fr
Pierre MAYER, MD
About this study
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.
- Conditions
- Biliary Tract Injuries
- Keywords
- Biliary tract injuries, Endoscopic treatment, Iatrogenic injuries of the bile ducts
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate of the initial endoscopic procedure
Success rate:
This is the percentage of patients for whom the treatment was successful Expressed as a percentage.
Example:
Out of 100 patients, if 85 improve, the success rate is 85%.
Measured: Immediately after surgery
Clinical success rate at 3 months after the end of treatment
Success rate:
This is the percentage of patients for whom the treatment was successful Expressed as a percentage.
Example:
If 100 patients are treated and 80 improve, the success rate is 80%.
Measured: 3 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start17 Oct 2025
- Primary completionApr 2027 (estimated)
- Study completion17 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345936
- Sponsor's protocol ID
- 9943
- Acronym
- EpSB
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Treatment of Post Surgical Biliary Tract Injury
- ClinicalTrials.gov ID
- NCT07345936
- Acronym / sponsor ID
- EpSB / 9943
- Conditions
- Biliary Tract Injuries
- Keywords
- Biliary tract injuries, Endoscopic treatment, Iatrogenic injuries of the bile ducts
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- 17 Apr 2027 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient 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)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Biliary wound occurring on a long cystic duct or gallbladder stump during partial cholecystectomy.
- Biliary leakage complicating liver transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical success rate of the initial endoscopic procedure
Time frame: Immediately after surgery
Success rate: This is the percentage of patients for whom the treatment was successful Expressed as a percentage. Example: Out of 100 patients, if 85 improve, the success rate is 85%.
Clinical success rate at 3 months after the end of treatment
Time frame: 3 months after the end of treatment
Success rate: This is the percentage of patients for whom the treatment was successful Expressed as a percentage. Example: If 100 patients are treated and 80 improve, the success rate is 80%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Injuries, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre MAYER, MD (33 3.69.55.15.03, pierre-emmanuel.mayer@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success rate of the initial endoscopic procedure (time frame: Immediately after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.