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临床试验/NCT05105828
NCT05105828已完成不适用

Predictive Power of Share Wave Fibro Scan in HCC After HCV Infection

Assiut University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
110
试验地点
1
主要终点
Shear wave elastography score

研究概览

简要总结

Shear wave electrography score allows stratification of HCC risk in a noninvasive and reliable way and can guide the surveillance strategy for HCC in patients with CLD

详细描述

Liver fibrosis is common to all chronic liver disease (CLD) , With time, this progressive disruption of hepatic architecture can develop into cirrhosis, characterized by "diffuse conversion of normal liver architecture into structurally abnormal nodules", About1% to 4% of patients with HCV-induced liver cirrhosis are diagnosed with HCC each year .

The historical gold standard for quantifying fibrosis is liver biopsy, but its invasive nature and potential for complications make it unpopular among patients and impractical for serial assessments of CLD. Furthermore, since histological lesions are not uniformly distributed across the liver parenchyma, this allows for large sampling error. The need for credible alternatives to biopsy has stimulated research into non-invasive methods of fibrosis assessment, including serum biomarkers , axial imaging and transient elastography.

FibroScan™ (Echosens, Paris, France) allows a non-invasive liver stiffness measurement (LSM), it is a relatively simple, highly reproducible and operator independent technique which examines an area 100 times that of a biopsy, reducing sampling bias , Shear wave elastography (SWE) measures LS by quantifying the velocity of shear waves produced in the liver tissue and uses a normal B-mode ultrasound probe for measuring LS in real time. In addition, SWE imaging using the Aixplorer system provides a high frame-rate and may be able to provide more accurate scoring of fibrosis .

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Post hepatitis C with HCC

排除标准

  • hepatic encephalopathy, ascites or pregnancy, hepatorenal syndrome or hepato-pulmonary syndrome, right side heart failure (liver congestion), extra hepatic tumors, history of liver transplantation, cholestasis, and hepatitis B patient

结局指标

主要结局

Shear wave elastography score

时间窗: through study completion, an average of 1 year

it measures liver stiffness as it is a rapid technique taking less than 5 min that can be easily performed at bedside or in outpatient clinic,according to the manufacturer's recommendations and the machine scale result ranges from 2.5 to 75 kPa with normal value around 5.5 kPa

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

Mariam Roshdy Elkhayat

Principle investigator

Assiut University

研究点 (1)

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