Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Postoperative Biliary Fistula Prevention After Hepatectomy by External Biliary Duct Stent:Prospective Multicenter Randomized Trial
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.