Postoperative Biliary Fistula Prevention After Hepatectomy (VPI)

March 31, 2026 updated by: University Hospital, Toulouse

Postoperative Biliary Fistula Prevention After Hepatectomy by External Biliary Duct Stent:Prospective Multicenter Randomized Trial

Aim : Effect of external biliary duct stent after hepatectomy on the occurence of postoperative biliary fistula.

Methods : French prospective multicenter randomized trial. Population study: Adult patients who underwent hepatectomy (> 2 segments) on non-cirrhotic liver.

Hypothesis: decreased postoperative biliary fistula from 15% to 5% with the presence of a external biliary duct stent. With this hypothesis, the number of patients required to be equal to 152 per group for a total of 304 patients.

Outcome measure: Primary : Postoperative biliary complications (biliary fistula, biloma, biliary peritonitis) Secondary : All morbidity, mortality, additional manoeuvres to treat biliary fistula, during of hospital stay and biliary fistula.

Follow up: A follow-up of patients 3 months after surgery for all patients. The planned total duration of the study is 3 years and 3 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After performing the hepatectomy and verification of hemostasis, patients were randomized (external biliary duct stent or not) by sealed envelopes. Systematic intraoperative test with methylene blue or air by the external biliary duct stent (EBDS) will necessary for all patients. Intra-abdominal drainage or not and type will be at the discretion of the surgeon. The EBDS will be left open for the first 7 postoperative days and then clamped. The EBDS will be removed during a consultation 5 weeks after surgery. Both groups of patients will be reviewed at 3 months after surgery, it will be noted at this point the possible complications related to the presence of EBDS (leakage from the drain, drop..). If patients are hospitalized more than five weeks, the study will stop at their consultation three months or the day of the consultation where the DTC is removed if it is still present at 3 months.

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • CHU
      • Clermont-Ferrand, France, 63003
        • Hotel Dieu
      • Lille, France, 59037
        • Hopital Claude Huriez
      • Marseille, France, 13273
        • Institut Paoli Calmettes
      • Marseille, France, 13385
        • CHU la Conception
      • Montpellier, France, 34295
        • Hôpital St Eloi
      • Nantes, France, 44093
        • Hotel Dieu
      • Paris, France, 75012
        • Hôpital Saint Antoine
      • Strasbourg, France, 67098
        • hôpital Haute Pierre
      • Villejuif, France, 94804
        • Hopital Paul Brousse
    • France
      • Clichy, France, France, 92118
        • Hopital Beaujon
      • Toulouse, France, France, 31000
        • Toulouse Purpan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject has given his informed consent and signed consent
  • Hepatectomy at least 2 segments of liver parenchyma for a benign or malignant disease by laparotomy
  • Not cirrhotic liver

Exclusion Criteria:

  • Surgery made in emergency
  • Surgery by laparoscopy
  • Need to draw up a bilic-digestive anastomosis
  • Liver cirrhosis
  • History of cholecystectomy
  • Resection of less than 2 segments
  • Preoperative jaundice (total bilirubin> 30 micromol / l)
  • Presence of preoperative biliary drainage
  • Patients requiring the installation of a drain transcystic during the operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: external biliary duct stent
'External Biliary duct stent in the bile duct by cystic way'
Procedure: External Biliary duct stent in the bile duct by cystic way
The size of the external biliary duct stent depending of cystic duct size
No Intervention: without external biliary duct stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative biliary fistula
Time Frame: 3 months after surgey
3 forms of diagnosis : bile in the intra-abdominal drainage; presence of an intra-abdominal collection of bile liquid (biloma); presence of an effusion of bile in the abdominal space (biliary peritonitis).
3 months after surgey

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: 3 months after surgey
additional maneuvers for treat biliary fistula, during of hospital stay, during of biliary fistula
3 months after surgey
Mortality
Time Frame: 3 months after surgery
3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Fabrice MUSCARI, MD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

July 4, 2011

First Submitted That Met QC Criteria

November 7, 2011

First Posted (Estimated)

November 10, 2011

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08 114 01
  • 2008-A01268-47 (Other Identifier: French ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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