White Test in Intra-operative Detection of Donor Biliary Leak in LDLTx.

NCT04451447 | Completed

• 1 other identifier: White test in LDLTx
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Biliary leak is a common complication after partial liver resection in living donor liver transplant. It debases the quality of the postoperative course and affects morbidity and mortality. Detecting and localizing sites of biliary leak intraoperatively through bile leakage testing is important as it helps in detection of bile leaking points on the cut surface and decrease post-operative bile leak. In this study we will assess the efficacy and sensitivity of using White test in comparison to conventional saline test in detecting intra operative bile leakage in liver donor. The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition, for localization of bile leakage. The use of fat emulsion in bile leakage tests does not require special equipment, contaminate the wound, cause allergic reaction or damage the bile duct and surrounding tissues.

Conditions

Bile Leak

Keywords

White test, Donor, liver transplantation, living donor

Outcome Measures

Primary Outcomes (1)

• Intra-operative detection of bile leak points

  Detection and suturing of bile leak points

  Immediate Intra-operative

Secondary Outcomes (2)

• post-operative bile leak

  Early post-operative (one month)

• Surgical site infection

  Early post-operative (one month)

Study Arms (2)

white test arm

EXPERIMENTAL

The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition, for localization of bile leakage.

Procedure: The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage.

Saline test arm

OTHER

The conventional intra-operative saline test, which involves injecting an isotonic sodium chloride solution through the cystic duct, has been used for detection of leaking points from the transected liver surface.

Procedure: Saline test (routine test)

Interventions

The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage. PROCEDURE

The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition, for localization of bile leakage.

white test arm

Saline test (routine test) PROCEDURE

The conventional intra-operative saline test, which involves injecting an isotonic sodium chloride solution through the cystic duct, has been used for detection of leaking points from the transected liver surface.

Saline test arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Potential donors must be healthy volunteers between the ages of 18 and 45 years.
• BMI must be up to 28.
• Blood group must be compatible; Rh compatibility was not a significant criterion.
• Donors should have normal liver function and no medical comorbidities.
• Liver biopsy was done to ensure that there is no occult hepatic pathology and to establish the degree of steatosis that should be less than 20%.
• Donors must have no history of upper abdominal surgery.

You may not qualify if:

• Intra operative vascular or biliary complication.

Sponsors & Collaborators

• Amr Abdelaal: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

SMOFlipid

Study Officials

• amr abdelaal, prof

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Compare one group with a historical cohort. masked outcome for the tested and control arms.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Model Details: Non randomized controlled Interventional trial Compare the study group with a historical cohort.

Study Record Dates

• First Submitted: June 27, 2020
• First Posted: June 30, 2020
• Study Start: March 20, 2019
• Primary Completion: June 15, 2020
• Study Completion: June 20, 2020
• Last Updated: June 30, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)