Actively 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)
Led by Giulia Manzini · Updated on 2025-03-14
210
Participants Needed
5
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 intraoperative identification of open bile ducts at the liver resection surface when it is administered retrograde through the cystic duct) in terms of prevention of postoperative BL within 30 days after surgery.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 who already had a cholecystectomy if the cystic stump can be identified and opened during surgery
- Ability to understand the nature and individual consequences of the clinical trial
- Informed consent documented by signature
You will not qualify if you...
- Previous cholecystectomy if the cystic stump cannot be identified during surgery
- Intraoperative hepatico-jejunostomy
- Hypersensitivity to fish, egg, soybean, peanut protein, or any ingredients in the study drug
- Immunosuppression or pregnancy
- Emergency liver resection due to traumatic liver rupture
- Investigator, family members, employees, or dependent persons enrolled in the study
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Department of Visceral Surgery, Cantonal Hospital of Aarau
Aarau, Switzerland, 5001
Actively Recruiting
2
Clarunis Basel, Universitäres Bauchzentrum Basel
Basel, Switzerland, 4031
Actively Recruiting
3
Kantonsspital Luzern
Lucerne, Switzerland, 6004
Actively Recruiting
4
Ospedale Regionale di Lugano
Lugano, Switzerland, 6900
Actively Recruiting
5
Kantonsspital St. Gallen
Sankt Gallen, Switzerland, 9001
Actively Recruiting
Research Team
G
Giulia Manzini, Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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