NCT01469442

Postoperative Biliary Fistula Prevention After Hepatectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatectomy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-05-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2011-11-10
• Last updated: 2026-04-06

Locations

12 sites across 1 country: France