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RECRUITING
NCT04523701
PHASE3

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)

Sponsor: Giulia Manzini

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2021-03-25

Completion Date

2025-12

Last Updated

2025-03-14

Healthy Volunteers

No

Conditions

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