Quantifying Steatosis in Liver Transplant Donors

Active, not recruiting

• Conditions: Evidence of Liver Transplantation; Non-alcoholic Fatty Liver Disease

• Registration Number: NCT02579408
• Lead Sponsor: The University of Hong Kong

Brief Summary

Non-alcoholic fatty liver disease is the most common chronic liver disease in Hong Kong. Its presence among donors of living donor liver transplants could affect the outcomes of recipients of liver transplantation. By using controlled attenuation parameter (CAP) measurements, the investigators aim to investigate the association of CAP measurements and severity of fatty liver among liver donors in the recipient outcomes of living donor liver transplantation.

Detailed Description

Living donor liver transplantation (LDLT) has been increasing worldwide due to the critical shortage of cadaveric donors and the rising number of patients awaiting liver transplantation. The long-term survival rates of LDLT are now comparable to that of deceased donor liver transplantation. Currently, two-thirds of all liver transplants performed in Hong Kong are LDLT.

The ultimate goal of LDLT is to guarantee donor safety while optimizing the best possible recipient outcome. Donor liver steatosis is a well-known factor which could influence graft function and long-term outcomes of the recipient allograft, and also affects donor hepatic recovery. When needed, pre-operative liver biopsy is often used for the quantitative assessment of donor steatosis, with LDLT not recommended when steatosis exceeds 30%. Nonetheless, liver biopsy is limited by its invasive nature, sampling error and intra-observer variations. Imaging evaluation for the quantification of steatosis via ultrasonography or computed tomography also has various pitfalls. There is currently no universal consensus on the ideal method in assessing donor steatosis.

Controlled attenuation parameter (CAP) is a novel non-invasive method to quantify hepatic steatosis using ultrasonic attenuations to postulate fat content. It has been demonstrated to have good correlation with the degree of hepatic steatosis in both Western and Asian populations. The investigators aim to evaluate the application of CAP in the donor workup of LDLT and to investigate for its association with post-transplant outcomes.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age 18-60 LDLT donor who has completed donor workup
• Consents to study entry

Exclusion Criteria

• Concomitant liver disease, including chronic hepatitis B and C infection, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson disease, and increased alcohol intake (30g per week for male, 20g per week for female).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recipient allograft short-term outcomes	Up to 30 days	Includes: 1. Intraoperative parameters (blood transfusion, operation time etc); 2. Postoperative outcomes (ICU stay, hospital stay, hospital mortality, major postoperative complication etc) Initial poor function, defined as an AST or ALT \>1,500 U/L on two consecutive measurements within the first 72 hours Primary graft nonfunction, defined as poor function of allograft culminating in either death of recipient or retransplant
Recipient allograft long-term outcomes	Up to 1 year	Includes: 1. Overall survival; 2. Primary graft nonfunction up to 1 year; 3. Liver stiffness measurements via transient elastography at 1 year; 4. Controlled attenuation parameter measurements at 1 year

Secondary Outcome Measures

Name	Time	Method
Association of controlled attenuation parameter scores with clinical parameters of LDLT donor	At time of transplant	Correlation of controlled attenuation parameter measurements with: 1. Body mass index (in kg/m2); 2. Waist circumference (in cm); 3. Liver volumetry and fat quantification via pre-operative computed tomography. Fat quantification is calculated by the hepatic attenuation measurement; 4. Donor histological grading of steatosis

Trial Locations

Locations (1)

Department of Medicine and Department of Surgery, The University of Hong Kong, Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong