NCT Number: NCT07451379
Comparison of Liver Biopsy Versus Fibroscan With CAP ( Controlled Attenuation Parameter) in Donors Evaluation for Liver Transplant
In our study we aiming that liver biopsy histological analysis as a reference standard, to examine the precision of fbroscan controlled attenuation parameter (CAP) for quantitative evaluation of macrovesicular steatosis in living related liver donors.
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–60 year
Sex eligibility
All sexes
Study type
Observational
About this study
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%.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Assiut University
Other
Registry information
Official study title
Comparison of Liver Biopsy Versus Fibroscan With CAP (Controlled Attenuation Parameter) in Donors Evaluation for Liver Transplant
Acronym: DonorFibroScan
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2027
- First posted
- Mar 5, 2026
- Registry last updated
- Mar 5, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.