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

NCT04451447 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-06-30

No results posted yet for this study

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

Interventions

PROCEDURE

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

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

Saline test (routine test)

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.

Sponsors & Collaborators

  • Amr Abdelaal

    lead OTHER

Principal Investigators

  • amr abdelaal, prof · Ain Shams University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-20
Primary Completion
2020-06-15
Completion
2020-06-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04451447 on ClinicalTrials.gov