Quantifying Steatosis in Liver Transplant Donors

• ClinicalTrials.gov Identifier: NCT02579408
• Recruitment Status: Active, not recruiting
• First Posted: October 19, 2015
• Last Update Posted: May 11, 2023
• Sponsor: The University of Hong Kong
• Information provided by (Responsible Party): Wai-Kay Seto, The University of Hong Kong

Tracking Information

• First Submitted Date: October 14, 2015
• First Posted Date: October 19, 2015
• Last Update Posted Date: May 11, 2023
• Study Start Date: October 2015
• Estimated Primary Completion Date: May 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 15, 2015)

• Recipient allograft short-term outcomes [ Time Frame: 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 [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 15, 2015)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Quantifying Steatosis in Liver Transplant Donors
• Official Title: Controlled Attenuation Parameter for the Evaluation of Donor Steatosis in Living Donor Liver Transplantation
• 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

Serum and plasma for storage in anticipation of future biomarkers for the prediction of improved post-transplant outcomes

• Sampling Method: Non-Probability Sample
• Study Population: Donors of living donor liver transplantation conducted in Queen Mary Hospital, Hong Kong

Condition

• Non-alcoholic Fatty Liver Disease
• Evidence of Liver Transplantation

• Intervention: Not Provided

Study Groups/Cohorts

LDLT donor

Donors of living donor-related liver transplantation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 15, 2015): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2026
• Estimated Primary Completion Date: May 2026 (Final data collection date for primary outcome measure)

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hong Kong

Administrative Information

• NCT Number: NCT02579408
• Other Study ID Numbers: CAP LDLT
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Wai-Kay Seto, The University of Hong Kong
• Original Responsible Party: Same as current
• Current Study Sponsor: The University of Hong Kong
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Wai Kay Seto, MD; The University of Hong Kong

• PRS Account: The University of Hong Kong
• Verification Date: May 2023