跳至主要内容
临床试验/NCT07451379
NCT07451379尚未招募不适用

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

Assiut University0 个研究点目标入组 100 人开始时间: 2026年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Diagnostic Accuracy of FibroScan Controlled Attenuation Parameter (CAP) for Quantitative Assessment of Macrovesicular Steatosis in Living Liver Donors: A Comparative Study with Liver Biopsy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All donors aged >18 years old
  • eligible for Liver Transplant

排除标准

  • -Subjects aged ≤18 years old.
  • Donors refused to do FibroScan with CAP

结局指标

主要结局

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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amira Mohammed Abdel Mowgod

Lecturer of Tropical Medicine and Gastroenterology

Assiut University

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