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)

NCT ID: NCT04523701

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-25
• Study Completion Date: 2025-12-31

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.

Conditions

Bile Leakage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Experimental Intervention (treatment)

Open bile ducts are identified by visual control of the liver resection surface combined with the direct injection in the cystic stump of 20-40ml of SMOFlipid 20% Fresenius Kabi Canada Ltd.; authorization number: 57231 (Swissmedic).

SMOFlipid is a white oily emulsion containing soya oil and medium chain triglycerides as main active components, normally used as parenteral nutrition as complement for essential fat acids supplementation. In this study the "white" test (= the administration of SMOFlipid retrograde through the cystic duct) is made by injection of one or two 20cc syringes full of lipidic solution (SMOFlipid 20%) in the cystic stump, directing the flow to the intrahepatic ducts. Residual fat emulsion is washed out from the biliary tract by a low pressure infusion of 20 to 50 ml of saline solution.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Control Intervention

Open bile ducts are identified in the control group by visual control of the liver resection surface combined with the use of white gauzes (standard procedure)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Giulia Manzini

OTHER

Sponsor Role: lead

Responsible Party

Giulia Manzini

Dr. med., Senior physician, Department of Visceral Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Giulia Manzini, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital of Aarau, Switzerland

Locations

Department of Visceral Surgery, Cantonal Hospital of Aarau

Aarau, , Switzerland

Site Status: RECRUITING

Clarunis Basel, Universitäres Bauchzentrum Basel

Basel, , Switzerland

Site Status: RECRUITING

Kantonsspital Luzern

Lucerne, , Switzerland

Site Status: RECRUITING

Ospedale Regionale di Lugano

Lugano, , Switzerland

Site Status: RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Giulia Manzini, Dr. med.

Role: CONTACT

giulia.manzini@ksa.ch

+41-62-8389734

Facility Contacts

Giulia Manzini, Dr. med.

Role: primary

giulia.manzini@ksa.ch

062-8389734

Otto Kollmar, Prof. Dr. med.

Role: primary

otto.kollmar@clarunis.ch

+41 61 777 73 20

Andreas Scheiwiller, Dr. med.

Role: primary

andreas.scheiwiller@luks.ch

041 2054539

Alessandra Cristaudi, Dr. med.

Role: primary

alessandra.cristaudi@eoc.ch

091 811 7208

Ignazio Tarantino, PD Dr. med.

Role: primary

Ignazio.tarantino@kssg.ch

071 4941312

References

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.

Reference Type: DERIVED

PMID: 34326053 (View on PubMed)

Other Identifiers

2020-02081; ex20Manzini

Identifier Type: -

Identifier Source: org_study_id