Postoperative Biliary Fistula Prevention After Hepatectomy

Toulouse University Hospital

Status: Completed

Conditions: Hepatectomy

Treatments: Procedure: External Biliary duct stent in the bile duct by cystic way

Study type: Interventional

Funder types: Other

Identifiers

NCT01469442

08 114 01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 304 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

304 participants in 2 patient groups

external biliary duct stent

Experimental group

Description:

'External Biliary duct stent in the bile duct by cystic way'

Treatment:

Procedure: External Biliary duct stent in the bile duct by cystic way

without external biliary duct stent

No Intervention group