Quantifying Steatosis in Liver Transplant Donors
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ClinicalTrials.gov Identifier: NCT02579408 |
Recruitment Status :
Active, not recruiting
First Posted : October 19, 2015
Last Update Posted : May 11, 2023
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Condition or disease |
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Non-alcoholic Fatty Liver Disease Evidence of Liver Transplantation |
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 : | May 2026 |
Estimated Study Completion Date : | May 2026 |
Group/Cohort |
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LDLT donor
Donors of living donor-related liver transplantation
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- Recipient allograft short-term outcomes [ Time Frame: Up to 30 days ]
Includes:
- Intraoperative parameters (blood transfusion, operation time etc)
- 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:
- Overall survival
- Primary graft nonfunction up to 1 year
- Liver stiffness measurements via transient elastography at 1 year
- Controlled attenuation parameter measurements at 1 year
- 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:
- Body mass index (in kg/m2)
- Waist circumference (in cm)
- Liver volumetry and fat quantification via pre-operative computed tomography. Fat quantification is calculated by the hepatic attenuation measurement
- Donor histological grading of steatosis
Biospecimen Retention: Samples Without DNA
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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 |
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).
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 ClinicalTrials.gov identifier (NCT number): NCT02579408
Hong Kong | |
Department of Medicine and Department of Surgery, The University of Hong Kong, Queen Mary Hospital | |
Hong Kong, 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 |
ClinicalTrials.gov Identifier: | NCT02579408 |
Other Study ID Numbers: |
CAP LDLT |
First Posted: | October 19, 2015 Key Record Dates |
Last Update Posted: | May 11, 2023 |
Last Verified: | May 2023 |
NAFLD LDLT steatosis CAP transient elastography |
Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Digestive System Diseases |