Non-alcoholic Fatty Liver DiseaseNCT02579408
Quantifying Steatosis in Liver Transplant Donors
An observational study of Non-alcoholic Fatty Liver Disease and Evidence of Liver Transplantation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Evidence of Liver Transplantation
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- Oct 2015to May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Donors of living donor liver transplantation conducted in Queen Mary Hospital, Hong Kong
Who may be able to join
- Age 18-60 LDLT donor who has completed donor workup
- Consents to study entry
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Medicine and Department of Surgery, The University of Hong Kong, Queen Mary Hospital
Hong Kong
About this study
Official title: Controlled Attenuation Parameter for the Evaluation of Donor Steatosis in Living Donor Liver Transplantation
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.
Read the 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.
- Keywords
- NAFLD, LDLT, steatosis, CAP, transient elastography
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LDLT donor | Donors of living donor-related liver transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recipient allograft short-term outcomes
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
Measured: Up to 30 days
Recipient allograft long-term outcomes
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
Measured: Up to 1 year
Secondary outcomes (1)
Association of controlled attenuation parameter scores with clinical parameters of LDLT donor
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
Measured: At time of transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wai-Kay Seto, The University of Hong Kong
- Investigators
- Wai Kay Seto, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579408
- Sponsor's protocol ID
- CAP LDLT
- Status last verified
- May 2023
- First submitted
- 14 Oct 2015
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Attenuation Parameter for the Evaluation of Donor Steatosis in Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT02579408
- Acronym / sponsor ID
- CAP LDLT
- Keywords
- NAFLD, LDLT, steatosis, CAP, transient elastography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDLT donor | – | –Donors of living donor-related liver transplantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Donors of living donor liver transplantation conducted in Queen Mary Hospital, Hong Kong
Key inclusion criteria (2 listed)
- Age 18-60 LDLT donor who has completed donor workup
- Consents to study entry
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Association of controlled attenuation parameter scores with clinical parameters of LDLT donor
Time frame: At time of transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wai Kay Seto, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease and Evidence of Liver Transplantation, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recipient allograft short-term outcomes (time frame: Up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.