Quantifying Steatosis in Liver Transplant Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02579408
Recruitment Status : Recruiting
First Posted : October 19, 2015
Last Update Posted : May 3, 2018
Information provided by (Responsible Party):
Wai-Kay Seto, 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.

Condition or disease
Non-alcoholic Fatty Liver Disease Evidence of 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 Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Controlled Attenuation Parameter for the Evaluation of Donor Steatosis in Living Donor Liver Transplantation
Study Start Date : October 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : March 2019

LDLT donor
Donors of living donor-related liver transplantation

Primary Outcome Measures :
  1. Recipient allograft short-term outcomes [ Time Frame: Up to 30 days ]


    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

  2. Recipient allograft long-term outcomes [ Time Frame: Up to 1 year ]


    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 :
  1. Association of controlled attenuation parameter scores with clinical parameters of LDLT donor [ Time Frame: 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

Biospecimen Retention:   Samples Without DNA
Serum and plasma for storage in anticipation of future biomarkers for the prediction of improved post-transplant outcomes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Donors of living donor liver transplantation conducted in Queen Mary Hospital, Hong Kong

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02579408

Contact: Wai Kay Seto, MD +85222553994

Hong Kong
Department of Medicine and Department of Surgery, The University of Hong Kong, Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Wai-Kay Seto, MD    +85222553994   
Principal Investigator: Wai-Kay Seto, MD         
Sub-Investigator: Kenneth SH Chok, FRCS         
Sub-Investigator: James Fung, MD         
Sponsors and Collaborators
The University of Hong Kong
Principal Investigator: Wai Kay Seto, MD The University of Hong Kong

Responsible Party: Wai-Kay Seto, Clinical Assistant Professor, The University of Hong Kong Identifier: NCT02579408     History of Changes
Other Study ID Numbers: CAP LDLT
First Posted: October 19, 2015    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

Keywords provided by Wai-Kay Seto, The University of Hong Kong:
transient elastography

Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases