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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)

NCT04523701 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2025-03-14

No results posted yet for this study

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.

Conditions

  • Bile Leakage

Interventions

DRUG

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

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

Sponsors & Collaborators

  • Giulia Manzini

    lead OTHER

Principal Investigators

  • Giulia Manzini, Dr. med. · Cantonal Hospital of Aarau, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04523701 on ClinicalTrials.gov