Using a fat emulsion to identify bile ducts during liver surgery to prevent bile leakage

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- A Randomized Controlled Multicentric Superiority Trial- The BiLe-Trial (Bile Leakage Trial)

This study is testing whether a special fat solution can help doctors see bile ducts better during liver surgery to prevent leaks and improve recovery for patients.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kantonsspital Aarau (Academic / other)
• Locations: 5 sites (Aarau and 4 other locations)
• Trial ID: NCT04523701 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of SMOFlipid 20%, a fat emulsion, administered retrograde through the cystic duct during liver resection surgeries. The goal is to enhance the intraoperative identification of open bile ducts, which can then be sutured to prevent bile leakage, a common complication following liver surgery. By reducing the incidence of bile leakage, the study aims to decrease the need for additional interventions and improve patient outcomes within 30 days post-surgery. The trial will include patients undergoing anatomical liver resections with simultaneous cholecystectomy.

Who should consider this trial

Good fit: Ideal candidates are patients scheduled for anatomical resection of two or more liver segments with simultaneous cholecystectomy.

Not a fit: Patients who have had a previous cholecystectomy where the cystic stump cannot be identified intraoperatively may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the rate of bile leakage after liver resection, leading to better recovery and fewer complications for patients.

How similar studies have performed: While the use of fat emulsions in surgical settings is not widely tested, the innovative approach of using SMOFlipid for bile duct identification represents a novel strategy that could lead to significant advancements in surgical outcomes.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Aarau and 4 other locations

• Department of Visceral Surgery, Cantonal Hospital of Aarau — Aarau, Switzerland (Recruiting)
• Clarunis Basel, Universitäres Bauchzentrum Basel — Basel, Switzerland (Recruiting)
• Kantonsspital Luzern — Lucerne, Switzerland (Recruiting)
• Ospedale Regionale di Lugano — Lugano, Switzerland (Recruiting)
• Kantonsspital St. Gallen — Sankt Gallen, Switzerland (Recruiting)

Study contacts

• Principal investigator: Giulia Manzini, Dr. med. — Cantonal Hospital of Aarau, Switzerland
• Study coordinator: Giulia Manzini, Dr. med.

Conditions Bile Leakage; Liver resection; SMOFlipid 20%; White Test