Clinical trial NCT02579408: Quantifying Steatosis in Liver Transplant Donors
Official title: Controlled Attenuation Parameter for the Evaluation of Donor Steatosis in Living Donor Liver Transplantation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-alcoholic Fatty Liver Disease
Evidence of Liver Transplantation
Keywords: NAFLD
LDLT
steatosis
CAP
transient elastography
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Donors of living donor liver transplantation conducted in Queen Mary Hospital, 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Recipient allograft short-term outcomes
timeFrame: Up to 30 days
measure: Recipient allograft long-term outcomes
timeFrame: Up to 1 year
Secondary outcomes:
measure: Association of controlled attenuation parameter scores with clinical parameters of LDLT donor
timeFrame: At time of transplant
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Medicine and Department of Surgery, The University of Hong Kong, Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Wai Kay Seto, MD
role: PRINCIPAL_INVESTIGATOR
References: