Postoperative Biliary Fistula Prevention After Hepatectomy
|ClinicalTrials.gov Identifier: NCT01469442|
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : January 5, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatectomy||Procedure: External Biliary duct stent in the bile duct by cystic way||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||304 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Postoperative Biliary Fistula Prevention After Hepatectomy by External Biliary Duct Stent:Prospective Multicenter Randomized Trial|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
Experimental: external biliary duct stent
'External Biliary duct stent in the bile duct by cystic way'
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
|No Intervention: without external biliary duct stent|
- Postoperative biliary fistula [ Time Frame: 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).
- Morbidity [ Time Frame: 3 months after surgey ]additional maneuvers for treat biliary fistula, during of hospital stay, during of biliary fistula
- Mortality [ Time Frame: 3 months after surgery ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01469442
|Amiens, France, 80054|
|Clermont Ferrand, France, 63003|
|Clichy, France, 92118|
|Hôpital Claude Huriez|
|Lille, France, 59037|
|Institut Paoli Calmettes|
|Marseille, France, 13273|
|CHU la conception|
|Marseille, France, 13385|
|Hôpital St Eloi|
|Montpellier, France, 34295|
|Nantes, France, 44093|
|Hôpital Saint Antoine|
|Paris, France, 75012|
|hôpital Haute Pierre|
|Strasbourg, France, 67098|
|Toulouse, France, 31000|
|Hôpital Paul Brousse|
|Villejuif, France, 94804|
|Principal Investigator:||Fabrice MUSCARI, MD||University Hospital, Toulouse|