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)

ConditionBile Leakage
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGiulia Manzini

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • "white" test" (= the administration of SMOFlipid retrograde through the cystic duct)

Treatment groups

210 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Giulia Manzini

Lead sponsor

Kantonsspital Aarau

Sponsor institution