An observational study in Non-alcoholic Fatty Liver Disease and Evidence of Liver Transplantation, sponsored by The University of Hong Kong. Active, not recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by The University of Hong Kong · Observational
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.
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 100 is below the median of 167 across 681 observational studies indexed under Liver Diseases.
Browse Liver Diseases studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Donors of living donor liver transplantation conducted in Queen Mary Hospital, Hong Kong
Exclusion Criteria:
Donors of living donor-related liver transplantation
Recipient allograft short-term outcomes
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
Time frame: Up to 30 days
Recipient allograft long-term outcomes
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
Time frame: Up to 1 year
Association of controlled attenuation parameter scores with clinical parameters of LDLT donor
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
Time frame: At time of transplant
This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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The University of Hong Kong