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 | Recruiting Phase 3

• 1 other identifier: 2020-02081; ex20Manzini
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 5

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.

Conditions

Bile Leakage

Keywords

Liver resection; SMOFlipid 20%; White Test

Outcome Measures

Primary Outcomes (1)

• 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.

  within 30 days postoperative

Secondary Outcomes (9)

• Severity of the bile leakage (Grade A, B or C according to the definition by Koch et al).

  within 30 days postoperative

• In-hospital mortality other than related to the bile leakage

  within 30 days postoperative

• In-Hospital morbidity other than related to the bile leakage

  within 30 days postoperative

• Endoscopic retrograde cholangio pancreatography (ERCP) (yes/no)

  within 30 days postoperative

• Percutaneous Transhepatic Cholangio Drainage (PTCD) (yes/no)

  within 30 days postoperative

Study Arms (2)

Experimental Intervention (treatment)

EXPERIMENTAL

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.

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

Control Intervention

NO 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)

Interventions

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

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

Experimental Intervention (treatment)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Giulia Manzini: lead

Study Sites (5)

Department of Visceral Surgery, Cantonal Hospital of Aarau

Aarau, 5001, Switzerland

RECRUITING

Clarunis Basel, Universitäres Bauchzentrum Basel

Basel, 4031, Switzerland

RECRUITING

Kantonsspital Luzern

Lucerne, 6004, Switzerland

RECRUITING

Ospedale Regionale di Lugano

Lugano, 6900, Switzerland

RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, 9001, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 34326053 DERIVED

Study Officials

• Giulia Manzini, Dr. med.

  Cantonal Hospital of Aarau, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulia Manzini, Dr. med.

CONTACT

+41-62-8389734; giulia.manzini@ksa.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients, care providers and outcome assessors are blinded, the surgical team is not blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med., Senior physician, Department of Visceral Surgery

Model Details: Prospective randomized, controlled, observer and patient blinded multicentric (4 centres) superiority trial with 2 parallel study groups

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: March 25, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

CH (5)