Postoperative Biliary Fistula Prevention After Hepatectomy
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|