Clinical trial NCT04523701: 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)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Bile Leakage
Keywords: Liver resection
SMOFlipid 20%
White Test
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized, controlled, observer and patient blinded multicentric (4 centres) superiority trial with 2 parallel study groups
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of postoperative bile leakage
timeFrame: within 30 days postoperative
Secondary outcomes:
measure: Severity of the bile leakage (Grade A, B or C according to the definition by Koch et al).
timeFrame: within 30 days postoperative
measure: In-hospital mortality other than related to the bile leakage
timeFrame: within 30 days postoperative
measure: In-Hospital morbidity other than related to the bile leakage
timeFrame: within 30 days postoperative
measure: Endoscopic retrograde cholangio pancreatography (ERCP) (yes/no)
timeFrame: within 30 days postoperative
measure: Percutaneous Transhepatic Cholangio Drainage (PTCD) (yes/no)
timeFrame: within 30 days postoperative
measure: Interventional drainage (yes/no)
timeFrame: within 30 days postoperative
measure: Re-operation (yes/no)
timeFrame: within 30 days postoperative
measure: Intensive care unit (ICU) stay (in days)
timeFrame: within 30 days postoperative
measure: Total hospital stay (in days)
timeFrame: within 30 days postoperative
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Department of Visceral Surgery, Cantonal Hospital of Aarau
city: Basel
country: Switzerland
facility: Clarunis Basel, Universitäres Bauchzentrum Basel
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
Study officials:
affiliation: Cantonal Hospital of Aarau, Switzerland
name: Giulia Manzini, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cristaudi A, Tarantino I, Scheiwiller A, Wiencierz A, Majno-Hurst P, Schmied BM, Metzger J, Hartel M, Kremer M, Manzini G. 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: study protocol for a randomised controlled multicentric superiority trial (BiLe-Trial). BMJ Open. 2021 Jul 29;11(7):e049449. doi: 10.1136/bmjopen-2021-049449.