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)

Phase 3RecruitingNCT04523701

Giulia Manzini210 enrolled

Overview

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.

Bile leakage (BL) is the most frequent complication after liver resection leading to the need of interventional drainage, endoscopic retrograde cholangio pancreatography (ERCP) or even reoperation. Strategies leading to a reduction of the rate of this complication are valuable. SMOFlipid 20% is a fat emulsion which is primary indicated for parenteral nutrition. Because of its fatty content this solution is white. This allows the clear intraoperative identification of open bile ducts at the liver resection surface when it is administered retrograde through the cystic duct. Consequently, open bile ducts can be sutured preventing the postoperative development of BL. If the rate of bile leakages can be reduced, resources for interventions and relaparotomy will be saved. This study is to investigate intraoperative administration of SMOFlipid 20% in terms of prevention of BL within 30 days after surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

210

Conditions

Bile Leakage

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

rate of postoperative bile leakage

Comparison of the rate of postoperative bile leakage in the control and in the intervention group. This is a binary endpoint defined by the presence or absence of the bile leakage (yes or no). Bile leakage is defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration on or after postoperative day 3.