Non Invasive Assessment of Liver Fibrosis in Children: Evaluation of Diagnostic Performances of ShearWave Elastography (SWE) and Fibrotest®/ Fibromax® by Comparison With Fibrosis Score on Liver Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- liver fibrosis evaluated by the ISHAK score and morphometric evaluation
研究概览
简要总结
The purpose of this study is to determine if SWE and Fibrotest®/ Fibromax®, alone or associated, are effective methods to assess liver fibrosis in children.
详细描述
Liver biopsy will be the gold standard to assess fibrosis using Ishak score and morphometric evaluation of fibrosis. All children included will have a measure of liver stiffness using SWE with 5 measures performed in the area where the biopsy is performed and 5 measures in an other place in the liver. Fibrotest®/ Fibromax® will be performed on blood sample. All exams will be done within 1 month. diagnostic performance of SWE and Fibrotest®/ Fibromax® will be assessed respectively. algorithm using the results of both technics will be tested in order to test diagnostic performance and to obtain better performances.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age < 18 years;
- •indication to liver biopsy;
- •informed consent of both parents and child if applicable;
- •social insurance
排除标准
- 未提供
研究组 & 干预措施
Shearwave electrography
Two experimental interventions will be realized in each patient in this population : Shearwave electrography (new diagnostic test of fibrosis) and Fibrotest .
Moreover, liver biopsies, the gold standard for the fibrosis diagnosis is also realized in each patient within usual cares.
干预措施: Shearwave electrography (Procedure)
结局指标
主要结局
liver fibrosis evaluated by the ISHAK score and morphometric evaluation
时间窗: up to 1 month
Histology is the gold standard to evaluate liver fibrosis
次要结局
- liver fibrosis evaluation : stiffness using SHEARWAVE elastography(up 1 month)
- Liver fibrosis evaluation using Fibrotest (Fibromax)(up 1 month)