Postoperative Biliary Fistula Prevention After Hepatectomy

Not Applicable

Completed

• Conditions: Hepatectomy
• Interventions: Procedure: External Biliary duct stent in the bile duct by cystic way

• Registration Number: NCT01469442
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

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 Timeline

• Study Start: 2009-05
• Study First Submitted: 2011-07-04
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-10
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-28
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
external biliary duct stent	External Biliary duct stent in the bile duct by cystic way	'External Biliary duct stent in the bile duct by cystic way'

Primary Outcome Measures

Name	Time	Method
Postoperative biliary fistula	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 Outcome Measures

Name	Time	Method
Morbidity	3 months after surgey	additional maneuvers for treat biliary fistula, during of hospital stay, during of biliary fistula
Mortality	3 months after surgery

Trial Locations

Locations (11)

Hotel Dieu; 🇫🇷 Nantes, France

Hôpital beaujon; 🇫🇷 Clichy, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

CHU la conception; 🇫🇷 Marseille, France

Hôpital St Eloi; 🇫🇷 Montpellier, France

Hôpital Claude Huriez; 🇫🇷 Lille, France

Hôpital Saint Antoine; 🇫🇷 Paris, France

hôpital Haute Pierre; 🇫🇷 Strasbourg, France

Toulouse Purpan; 🇫🇷 Toulouse, France

Hôpital Paul Brousse; 🇫🇷 Villejuif, France

CHU; 🇫🇷 Amiens, France