跳至主要内容
临床试验/NCT04384159
NCT04384159已完成不适用

Transient Versus Bidimensional Shear Wave Elastography in Serial Combination Strategy to Diagnose Advanced Fibrosis in NAFLD Patients

University Hospital, Montpellier0 个研究点目标入组 577 人开始时间: 2011年11月30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
577
主要终点
Diagnostic accuracyclassification

研究概览

简要总结

Serial combination of biological and elastography tests is accurate to diagnosing advanced fibrosis in non-alcoholic fatty liver disease (NAFLD) patients. In this study, the investigators compared the diagnostic performances of a 2-step strategy using either vibration-controlled transient elastography (VCTE) or bidimensional shear wave elastography with Supersonic imagine (2D-SWE-SSI), and analysed the added-value of a 3-step strategy.

详细描述

The investigators retrospectively selected all consecutive adult patients with suspicion of NAFLD who had undergone liver biopsy from November 2011 to July 2019 in 2 French academic centers, Angers and Bordeaux university hospitals. A total of 577 patients were included. Among them, 291 had been previously included in a prospective study comparing diagnostic performances of several non-invasive tests in NAFLD patients. Inclusion criteria were: Age≥18yo, 2D-SWE-SSI and VCTE performed within the two weeks prior to liver biopsy. Exclusion criteria were high alcohol consumption (i.e., >21 drinks, on average, per week in men and >14 drinks, on average, per week in women), associated causes of liver disease (alcoholic, viral, or other causes of liver injury), other aetiologies than NAFLD on pathological examination, and a liver biopsy length of less than 10 mm and/or fewer than 6 portal spaces and/or more than 2 fragments, except for in cases of cirrhosis.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Diagnostic accuracyclassification

时间窗: 1 day

Diagnostic accuracyclassification

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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Combination Diagnostic Strategies in NAFLD | 临床试验