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NCT Number: NCT07345936

Endoscopic Treatment of Post Surgical Biliary Tract Injury

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.

Recruiting

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Key information

Conditions

Biliary Tract Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Hépato-gastroentérologie - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Carlota SILJESTRÖM BERENGUER, MD

SUB_INVESTIGATOR

Julien GODET, Statistician

SUB_INVESTIGATOR

Pierre MAYER, MD

CONTACT

[email protected]

33 3.69.55.15.03

Pierre MAYER, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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%.

  2. 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%.

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre MAYER, MD

CONTACT

[email protected]

33 3.69.55.15.03

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: EpSB

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 16, 2026
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.