Comparison of Liver Biopsy Versus Fibroscan With CAP ( Controlled Attenuation Parameter) in Donors Evaluation for Liver Transplant (DonorFibroScan)
Comparison of Liver Biopsy Versus Fibroscan With CAP (Controlled Attenuation Parameter) in Donors Evaluation for Liver Transplant
Study Overview
Status
Conditions
Detailed Description
To reduce waitlist mortality in living donor liver transplantation (LDLT) there are ongoing efforts to expand the living liver donor pool. Simultaneously, the prevalence of nonalcoholic fatty liver disease (NAFLD) in the general population has increased from 15% to 25% since 2005, which has significant implications on the pool of potential living liver donors.
Hepatic steatosis is one of the most frequent chronic parenchymatous liver changes in healthy people, and it can prevent a healthy donor from transplantation, because fatty changes that affect the graft's longevity can also affect the donor's own liver function.
The liver biopsy is the most crucial procedure for the identification and measurement of hepatic steatosis. Nevertheless, this approach is still invasive and exposes users to the danger of bleeding and infection, and is frequently only performed on carefully chosen donors and is not appropriate for screening or tracking.
The controlled attenuation parameter (CAP) using fbroscan M or XL probe has been created for hepatic steatosis evaluation. In individuals with non-alcoholic fatty liver disease (NAFLD), moderate steatosis has been shown to respond favourably to CAP.
Due to the limitations of biopsy, many noninvasive methods, particularly radiological methods for the assessment of steatosis, have emerged. These methods include CAP, US assessment, CT, magnetic reso-nance imaging (MRI), and liver stiffness measurements (LSMs) based on US signal.
Numerous benefits of the CAP determined by TE, such as its noninvasive, non ionizing, quantitative, quick, and repeatable characteristics, indicate that this parameter may be an effective method for identifying prospective living liver transplants.The CAP determined by TE has been used in numerous but small investigations to assess hepatic steatosis in living liver donations.
The efectiveness of CAP for identifying steatosis in 55 living liver donation prospects was assessed. They discovered that using US-guided liver biopsy as the reference standard, the AUROC ( Area Under the Receiver Operating Characteristic Curve) of CAP for detecting complete steatosis (>33%) was 0.88 with a cutoff value of 276 dB/m. Fifty-four living donors were evaluated using the CAP in a different research , and the outcomes were compared with those from intra-operative biopsy. With a cutoff value of 257 dB/m in that research, the CAP had an AUROC of 0.96 for identifying complete steatosis (>5%).
In a different study in 204 living donors were evaluated using CAP measurement and compared to the histological results for biopsy with only Mas being taken into account and MiS being excluded from the study. It was found that CAP had an AUROC of 0.938 for MaS 10% with a sensitivity of 84.2% and a specifcity of 92.4%.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Amira M. Abdelmawgod, Lecturer, Tropical Medicine
- Phone Number: +201012760437
- Email: amiramohmad60@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- After obtaining the appropriate consents, data pertaining to clinical history (name, age, sex, residence, occupation, co-morbidities… diabetes, hyperlipidemia, hypertension, ischemic heart disease, special habits; such as alcohol intake).
- blood samples will be collected for CBC. ( Hb level , WBCs, Platelets), liver function tests (albumin, alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transpeptidase, total bilirubin), lipid profile (total cholesterol, triglyceride, LDL), CRP, serum uric acid, HbA1c, and Kidney function test(serum urea and creatinine).
- Six measurements will be obtained (sex, age, height, weight, body mass index, and waist circumference).
Overweight is defined as BMI ≥25 kg/m² and obesity is defined as: BMI ≥30 kg/m².
- Imaging for evaluation of donors with BMI ≥25 kg/m² such as abdominal US and FibroScan with CAP.
- Donors with BMI ≥25 kg/m² will receive life style modification and medical treatment for improvement of steatosis
Description
Inclusion Criteria:
- All donors aged >18 years old
- eligible for Liver Transplant
Exclusion Criteria:
- -Subjects aged ≤18 years old.
- Donors refused to do FibroScan with CAP
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diagnostic Accuracy of FibroScan Controlled Attenuation Parameter (CAP) for Quantitative Assessment of Macrovesicular Steatosis in Living Liver Donors: A Comparative Study with Liver Biopsy
Time Frame: 24 month
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This study aims to evaluate the diagnostic accuracy of FibroScan Controlled Attenuation Parameter (CAP) for the quantitative assessment of macrovesicular hepatic steatosis in living related liver donors, using liver biopsy histopathological analysis as the reference standard
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24 month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 04-2026-300794
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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