Postoperative Biliary Fistula Prevention After Hepatectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hepatectomy

Intervention / Treatment
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* Procedure: External Biliary duct stent in the bile duct by cystic way


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biliary fistula, prevention, hepatectomy, external stent, Hepatectomy of more 2 segments, Not emergency or laparoscopy surgery