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Comparison of Liver Biopsy Versus Fibroscan With CAP ( Controlled Attenuation Parameter) in Donors Evaluation for Liver Transplant

Comparison of Liver Biopsy Versus Fibroscan With CAP (Controlled Attenuation Parameter) in Donors Evaluation for Liver Transplant

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07451379
Acronym
DonorFibroScan
Enrollment
100
Registered
2026-03-05
Start date
2026-07-01
Completion date
2027-07-01
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-invasive Donor Liver Assessment

Brief summary

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.

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%.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic Accuracy of FibroScan Controlled Attenuation Parameter (CAP) for Quantitative Assessment of Macrovesicular Steatosis in Living Liver Donors: A Comparative Study with Liver Biopsy24 monthThis 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

Contacts

CONTACTAmira M. Abdelmawgod, Lecturer, Tropical Medicine
amiramohmad60@gmail.com+201012760437

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026