Status:
COMPLETED
Postoperative Biliary Fistula Prevention After Hepatectomy
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Hepatectomy
Eligibility:
All Genders
18+ years
Phase:
NA
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 pat...
Detailed 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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT01469442
Start Date
May 1 2009
End Date
September 1 2017
Last Update
July 29 2020
Active Locations (12)
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1
CHU
Amiens, France, 80054
2
Hotel Dieu
Clermont-Ferrand, France, 63003
3
Hôpital beaujon
Clichy, France, 92118
4
Hôpital Claude Huriez
Lille, France, 59037