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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: giulia.manzini@ksa.ch
• Phone: +41-62-8389734

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.