Routine Intraoperative White Test for Bile Leak Detection in Liver Resection

NCT07511907 | Not Yet Recruiting

• 1 other identifier: KB/47/2026
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Bile leakage (BL) remains one of the most frequent complications following liver resection and is associated with increased postoperative morbidity and mortality, higher reintervention rates, prolonged hospital stay, and increased healthcare costs. Effective intraoperative identification and closure of open bile ducts may reduce the risk of postoperative BL. The White Test, which involves retrograde injection of a lipid emulsion into the biliary tree, enables active detection of bile leaks during surgery; however, its routine use has not been established in randomized clinical trials across all types of liver resection. This is a single-center, prospective, randomized, parallel-group, single-blinded superiority trial designed to evaluate the effectiveness of routine intraoperative use of the White Test compared with standard intraoperative bile leak detection using a white gauze test. Adult patients undergoing elective liver resection (major or minor, including both anatomic and non-anatomic resections) who meet eligibility criteria will be enrolled after providing written informed consent. Participants will be randomized in a 1:1 ratio to either the intervention group (White Test) or the control group (standard gauze test), using stratified block randomization according to the type of resection (major vs minor). Allocation will be concealed using sequentially numbered, opaque, sealed envelopes. Patients will remain blinded to group assignment, while the operating surgeon cannot be blinded due to the nature of the intervention. In the intervention group, following completion of liver parenchymal transection and achievement of hemostasis, the cystic duct stump will be identified and cannulated. The distal bile duct will be temporarily occluded, and 10-20 mL of lipid emulsion will be injected retrogradely into the biliary tree. The transection surface will be inspected for leakage of the white emulsion. Identified leaks will be managed by ligation or suturing, and the test may be repeated until no further leakage is observed. In the control group, bile leak detection will be performed by applying sterile white gauze to the transection surface with visual inspection, followed by suturing of identified leaks as needed. All patients will have intra-abdominal drainage placed at the resection site. Drain fluid bilirubin concentration will be measured on postoperative day three. Patients will be followed for 30 days after surgery. The primary outcome is the incidence of postoperative bile leakage within 30 days, defined according to the International Study Group of Liver Surgery (ISGLS) criteria. Secondary outcomes include severity of bile leakage (ISGLS grades A-C), postoperative morbidity (Clavien-Dindo classification), need for postoperative interventions (endoscopic, radiological, or surgical), intensive care unit (ICU) admission and length of ICU stay, and total hospital length of stay. The primary analysis will follow the intention-to-treat principle and will be performed separately within strata defined by resection type (major vs minor). Secondary and subgroup analyses will be considered exploratory. No formal interim analysis is planned; however, patient safety will be continuously monitored throughout the study. The results of this trial are expected to clarify the role of routine intraoperative White Test in liver surgery and its potential to reduce postoperative bile leakage and improve clinical outcomes.

Conditions

Bile Leak; Bile Leakage; Liver Resection; Hepatectomy; Bile Duct Disorder

Keywords

liver resection; hepatectomy; bile ducts; white test

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative bile leakage

  Occurrence of bile leakage within 30 days after liver resection, defined according to the International Study Group of Liver Surgery (ISGLS) criteria as bilirubin concentration in drain fluid at least three times higher than serum bilirubin on or after postoperative day 3, or the need for intervention due to bile leakage.

  Within 30 days after surgery

Secondary Outcomes (3)

• Severity of bile leakage

  Within 30 days after surgery

• Postoperative morbidity

  Within 30 days after surgery

• Postoperative interventions

  Within 30 days after surgery

Other Outcomes (2)

• ICU admission and length of stay

  Within 30 days after surgery

• Hospital length of stay

  Within 30 days after surgery

Study Arms (2)

Intervention Arm - White Test

EXPERIMENTAL

Participants assigned to this arm will undergo intraoperative bile leak detection using the White Test. After completion of liver parenchymal transection and achievement of hemostasis, the cystic duct stump will be cannulated, and the distal bile duct will be temporarily occluded. A lipid emulsion (10-20 mL) will be injected retrogradely into the biliary tree. The transection surface will be inspected for leakage of the white emulsion. Identified leaks will be managed by ligation or suturing, and the test may be repeated until no further leakage is observed.

Procedure: White Test

Control Arm - Standard Gauze Test

ACTIVE COMPARATOR

Participants assigned to this arm will undergo standard intraoperative bile leak detection using a sterile white surgical gauze applied to the liver transection surface. The gauze and transection site will be inspected for evidence of bile leakage. Identified leaks will be managed by ligation or suturing, and the assessment may be repeated as needed according to standard surgical practice.

Procedure: Standard Gauze Test

Interventions

White Test PROCEDURE

The White Test is an intraoperative technique for bile leak detection performed after completion of liver parenchymal transection and achievement of hemostasis. The cystic duct stump is cannulated, and the distal bile duct is temporarily occluded. A lipid emulsion (10-20 mL) is injected retrogradely into the biliary tree to increase intrabiliary pressure and enable visualization of bile leaks at the transection surface. Detected leaks are managed by ligation or suturing, and the test may be repeated until no further leakage is observed.

Intervention Arm - White Test

Standard Gauze Test PROCEDURE

The standard gauze test is a conventional intraoperative method for bile leak detection. A sterile white surgical gauze is applied to the liver transection surface, and both the gauze and the surgical field are visually inspected for evidence of bile leakage. Detected leaks are managed by ligation or suturing, and the assessment may be repeated as needed according to standard surgical practice.

Control Arm - Standard Gauze Test

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Undergoing elective liver surgery (regardless its modality): a) major hepatectomy OR b) minor hepatectomy (anatomic liver resection or non-anatomic liver resection).
• Possibility of performing the WT: intraoperative, simultaneous cholecystectomy or prior cholecystectomy with identifiable cystic stump allowing bile duct access.
• Written informed consent.

You may not qualify if:

• Undergoing intraoperative hepaticojejunostomy.
• Previous cholecystectomy without accessible cystic stump.
• Unresectable disease found intraoperatively.
• Allergy to SMOFlipid 5% components.
• Pregnancy or lactation.
• Emergency liver resection.
• Refusal for participation in trial.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of General, Transplant and Liver Surgery, Medical Univeristy of Warsaw

Warsaw, Masovian Voivodeship, 02-097, Poland

Location

MeSH Terms

Conditions

Bile Duct Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Piotr Remiszewski, MD, PhD

  Medical University of Warsaw

  STUDY DIRECTOR

• Paweł Topolewski, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

• Michał Grąt, Professor (Full), MD, PhD,

  Medical University of Warsaw

  STUDY CHAIR

Central Study Contacts

Paweł Topolewski, MD

CONTACT

+48 22 599 25 45; pawel.topolewski@wum.edu.pl

Piotr Remiszewski, MD, PhD

CONTACT

+48 22 599 25 45; piotr.remiszewski@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Masking Description If there are other parties who are masked in the clinical trial besides those listed above, use this space to describe those parties.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Model Description If needed, include additional details about the Interventional Study Model. 1,000 characters allowed

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)