Routine White Test for Early Detection of Bile Leak in Elective Liver Resection (DELiveR Trial)

NCT07511907 | Not Yet Recruiting DMC

• 1 other identifier: KB/47/2026
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

Bile leakage is a clinically important complication following liver resection and is associated with increased postoperative morbidity, need for reintervention and prolonged hospitalisation. The White Test involves retrograde injection of a white lipid emulsion into the biliary tree to facilitate active identification of open bile ducts on the liver transection surface. However, the benefit and safety of its routine use across different types of liver resection remain uncertain. The DELiveR Trial is a single-centre, prospective, randomised, parallel-group, participant- and outcome-assessor-blinded superiority trial. A total of 270 adults undergoing elective major or minor liver resection will be randomised in a 1:1 ratio to the White Test or a standardised white gauze assessment. Final eligibility will be confirmed intraoperatively after confirmation of resectability, completion of liver parenchymal transection and haemostasis, and confirmation that a cystic duct or cystic duct stump can be safely approached for attempted cannulation. Randomisation will then be performed using a computer-generated sequence with permuted blocks and concealed allocation. The White Test will involve slow, manual, low-pressure retrograde injection of 10-20 mL of SMOFlipid 5%, with temporary distal bile duct occlusion. Injection will be discontinued if abnormal resistance is encountered. Identified leakage sites will be clipped, ligated or sutured. The control group will undergo a standardised white gauze assessment according to a study-specific operating procedure. All participants will have an intra-abdominal drain placed. Serum and drain-fluid bilirubin concentrations will be measured concurrently on postoperative day 3. Participants will be followed for 30 days. The primary outcome is postoperative bile leakage within 30 days according to the International Study Group of Liver Surgery definition. The primary analysis will be conducted in the overall intention-to-treat population using logistic regression. Major versus minor hepatectomy will be evaluated only in exploratory subgroup and interaction analyses. Secondary outcomes include clinically relevant grade B/C bile leakage, postoperative morbidity, major morbidity, reinterventions, intensive care unit use, hospital length of stay, readmission, mortality and potential intervention-related adverse events. An independent Data and Safety Monitoring Committee will periodically review safety data.

Conditions

Bile Leak; Liver Resection; Hepatectomy

Keywords

liver resection; hepatectomy; bile ducts; white test

Outcome Measures

Primary Outcomes (1)

• Postoperative bile leakage according to the ISGLS definition

  Number and proportion of participants with postoperative bile leakage within 30 days after liver resection, defined as drain-fluid bilirubin concentration at least three times the concurrent serum bilirubin concentration on or after postoperative day 3, or the need for an intervention due to a biliary collection or biliary peritonitis.

  Within 30 days after surgery

Secondary Outcomes (11)

• Clinically relevant postoperative bile leakage

  Within 30 days after surgery

• Severity of postoperative bile leakage

  Within 30 days after surgery

• Overall postoperative morbidity

  Within 30 days after surgery

• Major postoperative morbidity

  Within 30 days after surgery.

• Postoperative interventions

  Within 30 days after surgery.

Study Arms (2)

Intervention Arm - White Test

EXPERIMENTAL

Participants allocated to this arm will undergo the White Test after completion of liver parenchymal transection and haemostasis. A cystic duct or cystic duct stump will be cannulated, and the distal extrahepatic bile duct will be temporarily occluded below the cystic duct insertion. SMOFlipid 5% will be administered retrogradely in a volume of 10-20 mL using slow, manual, low-pressure injection. Forceful injection will not be permitted, and injection will be discontinued if abnormal resistance is encountered. Identified leakage sites will be clipped, ligated or sutured, and the test may be repeated until no further leakage is observed. The biliary tree will subsequently be flushed with 20-50 mL of sterile 0.9% sodium chloride solution.

Procedure: White Test

Control Arm - Standard Gauze Test

ACTIVE COMPARATOR

Participants allocated to this arm will undergo a standardised white gauze assessment after completion of liver parenchymal transection and haemostasis. Sterile white surgical gauze will be systematically applied to the liver transection surface, and both the gauze and the transection surface will be inspected for visible biliary staining. Identified leakage sites will be clipped, ligated or sutured, and the assessment may be repeated until no further visible leakage is identified. The procedure will be conducted according to a written study-specific standard operating procedure. Alternative active intraoperative bile leak tests will not be permitted as part of the assigned control procedure.

Procedure: Standard Gauze Test

Interventions

White Test PROCEDURE

The White Test is an active intraoperative bile leak assessment performed after completion of liver parenchymal transection and haemostasis. It involves slow, manual, low-pressure retrograde injection of 10-20 mL of SMOFlipid 5% through a cannulated cystic duct or cystic duct stump while the distal extrahepatic bile duct is temporarily occluded. The liver transection surface is inspected for leakage of white emulsion. Identified open bile ducts are clipped, ligated or sutured, 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

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

You may qualify if:

• Age 18 years or older.
• Undergoing elective major or minor liver resection, including anatomical or non-anatomical liver resection.
• Technical eligibility for an attempted White Test, defined as the presence of an identifiable cystic duct or cystic duct stump that can be safely approached for attempted cannulation, as assessed intraoperatively after confirmation of resectability, completion of liver parenchymal transection and achievement of haemostasis.
• Written informed consent.

You may not qualify if:

• Intraoperative hepaticojejunostomy.
• Absence of a cystic duct or cystic duct stump that can be safely approached for attempted cannulation, as determined intraoperatively before randomisation.
• Unresectable disease identified intraoperatively.
• Known allergy to components of SMOFlipid 5%.
• Pregnancy or lactation.
• Emergency liver resection.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

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

Warsaw, Masovian Voivodeship, 02-097, Poland

Location

Study Officials

• Piotr Remiszewski, MD, PhD

  Medical University of Warsaw

  STUDY DIRECTOR

• Paweł Topolewski, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

• Michał Grąt, 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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will remain blinded to treatment allocation throughout the 30-day follow-up period. The operating surgical team cannot be blinded after allocation because of the nature of the intervention. The primary outcome will be assessed by an investigator who was not involved in the index surgical procedure and who will remain blinded to treatment allocation. The assessor will review a predefined adjudication dataset from which allocation-revealing information will be withheld.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomised in a 1:1 ratio to the White Test or standardised white gauze assessment using a computer-generated sequence with permuted blocks. Final intraoperative eligibility will be confirmed after completion of liver parenchymal transection and haemostasis and before randomisation. The primary analysis will compare the two groups in the overall intention-to-treat population. Major versus minor hepatectomy will be evaluated only in prespecified exploratory subgroup and interaction analyses.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available beginning 12 months after publication of the primary trial results and will remain available for five years.
• Access Criteria: Access will be considered for researchers who submit a methodologically sound proposal. Requests will be reviewed by the study investigators and sponsor, and access will require compliance with applicable data protection requirements and execution of a data-use agreement.

Locations

PL (1)