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临床试验/NCT01268865
NCT01268865Unknown不适用

Clinical Application of Acoustic Radiation Force Impulse (ARFI)Technology in Prediction of Liver Fibrosis in HBV and HCV-infected Patients

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1

研究概览

简要总结

Background: In patients with chronic liver diseases, liver fibrosis staging is crucial for hazard evaluation of future disease complication development and thus for the optimal decision making on treatment selections.In the era of antiviral and antifibrotic treatments, clinical and research demands are also increasing for non-invasive surveillance of liver fibrosis to evaluate the progression or regression. However, local baseline data on liver stiffness measurement (LSM) using ARFI technique is still lacking in Taiwan, where viral hepatitides are highly endemic. Aim: Using the ARFI elastosonography, we are dedicated to the aims to recruit patients based on strict but appropriate criteria, to complete the correlation and validity studies between ARFI quantification and the referenced METAVIR fibrosis scoring and to conduct subsequent innovative studies on liver diseases. Materials and Methods: We plan to perform the ARFI quantification for each HBV or HCV-infected patient immediately followed by priorly scheduled conventional liver biopsy for METAVIR scoring during the same session of examination. Statistics: The first year's study using ARFI will focus on the correlation testings and validity studies using receiver operating characteristics.

详细描述

Contribution and Future Works: Using the ARFI quantification either as a causal factor or as a outcome, we can conduct future analyses ranging from validations, regressions to prospective time-to-event analysis among our cohorts.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • infected with HBV only or HCV only

排除标准

  • concurrent HBV-HCV infection, etc.

研究者

申办方类型
Other

研究点 (1)

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