Skip to main content
OpenTrials
Completed

NCT Number: NCT01469442

Postoperative Biliary Fistula Prevention After Hepatectomy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital beaujon, Clichy, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

External Biliary duct stent in the bile duct by cystic way

Procedure

The size of the external biliary duct stent depending of cystic duct size

Primary outcomes

  1. 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).

Secondary outcomes

  1. Morbidity

    Time frame: 3 months after surgey

    additional maneuvers for treat biliary fistula, during of hospital stay, during of biliary fistula

  2. Mortality

    Time frame: 3 months after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: VPI

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Nov 10, 2011
Registry last updated
Apr 6, 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.

Published trials that share one or more normalized conditions with this study.