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临床试验/NCT01072721
NCT01072721已完成不适用

Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of FIBROSCANN.

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2010年1月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
264
试验地点
2
主要终点
To study the diagnosis value of hepatic elasticity measured by FIBROSCANN ® about fibrosis degree in comparison with hepatic biopsy (GOLDSTANDART) in a paediatric hepatic diseases cohort.

研究概览

简要总结

Early diagnosis of liver fibrosis is useful for the follow-up and treatment of chronic liver disease. At present, the unique validated method to evaluate the liver fibrosis in children, is the liver biopsy which is an invasive method. If the elastometry method is proved to be a good method to evaluate the fibrosis in children, a numerous liver biopsy could be avoided.

详细描述

The elastometry method is proved to be efficient for the evaluation of liver fibrosis in adults. But the inter-costal space is too thin in children, and the adult probe could not be used. Recently a special probe adapted to the children have been TECHNICATED. We want to test this specific probe in children. Five French Paediatrics centres will participate to the study. We need 200 children inclusions in 2 years to have a statistically power analysis. Inclusion of each child will be in order to the need of a liver biopsy. Each children included will have an elastometry measure in the same time than the liver biopsy. The fibrosis will be staged by a trained pathologist and scored by METAVIR score witch is the reference. The elastometry measure will be realised by physician with 3 sequential measures in each child. The statistical analysis will be performed by statistician. If elastometry is proved to be an efficient method to evaluate the liver fibrosis in children, a numerous of liver biopsy could be avoided. Because elastometry is a non invasive method it could also be used as follow-up in different categories of children who needs sequential liver biopsy.

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
6 Months 至 18 Years(Child, 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

研究组 & 干预措施

Fibrosis group

Other

a single arm with the two interventions (elastometry and biopsy)

干预措施: Elastometry (Other)

结局指标

主要结局

To study the diagnosis value of hepatic elasticity measured by FIBROSCANN ® about fibrosis degree in comparison with hepatic biopsy (GOLDSTANDART) in a paediatric hepatic diseases cohort.

时间窗: until two months

次要结局

  • For a better estimation of the fibrosis degree, after measuring the global nature of the liver, by decreasing the sampling bias.(two months)
  • For a best follow-up of the fibrosis to optimize the treatment.(two months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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