Status:
RECRUITING
Diagnostic Role of the "White Test" With Lipidic Solution in the Early Intraoperative Identification of Open Bile Ducts for the Prevention of Bile Leakage After Liver Resection (BiLe -Trial)
Lead Sponsor:
Giulia Manzini
Conditions:
Bile Leakage
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Bile leakage (BL) is the most frequent complication after liver resection. This study is to investigate the role of intraoperative administration of SMOFlipid 20% (fat emulsion which allows intraopera...
Detailed Description
Bile leakage (BL) is the most frequent complication after liver resection leading to the need of interventional drainage, endoscopic retrograde cholangio pancreatography (ERCP) or even reoperation. St...
Eligibility Criteria
Inclusion
- Patients who will receive an anatomical resection of two or more liver segments for any reason with simultaneous cholecystectomy in elective Setting
- Patients who will receive an anatomical resection of two or more liver segments for any reason which already had a cholecystectomy if intraoperatively the cystic stump can be identified and opened
- Ability of subject to understand character and individual consequences of the clinical Trial
- Informed consent documented by signature
Exclusion
- Previous cholecystectomy if intraoperative it is not possible to identify the cystic stump
- Intraoperative hepatico-jejunostomy
- Hypersensitivity to fish-, egg-, soybean or peanut protein or to any of the active ingredients or excipients
- Immunosuppression, pregnancy
- Emergency liver resection because of traumatic liver rupture
- Enrolment of the investigator, his/her family members, employees and other dependent persons
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04523701
Start Date
March 25 2021
End Date
December 1 2025
Last Update
March 14 2025
Active Locations (5)
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1
Department of Visceral Surgery, Cantonal Hospital of Aarau
Aarau, Switzerland, 5001
2
Clarunis Basel, Universitäres Bauchzentrum Basel
Basel, Switzerland, 4031
3
Kantonsspital Luzern
Lucerne, Switzerland, 6004
4
Ospedale Regionale di Lugano
Lugano, Switzerland, 6900