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RecruitingPhase 3NCT04523701

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)

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)

Sponsor

Giulia Manzini

Enrollment

210 participants

Start Date

Mar 25, 2021

Study Type

INTERVENTIONAL

Conditions

Bile Leakage

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 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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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
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Interventions

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

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

Locations(5)

Department of Visceral Surgery, Cantonal Hospital of Aarau

Aarau, Switzerland

Clarunis Basel, Universitäres Bauchzentrum Basel

Basel, Switzerland

Kantonsspital Luzern

Lucerne, Switzerland

Ospedale Regionale di Lugano

Lugano, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

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NCT04523701