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临床试验/NCT01613625
NCT01613625已完成不适用

Interest Of Renal Elastography In Children As A Diagnostic Tool Of Renal Fibrosis: Confrontation To Histological Features Of Renal Biopsies

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2011年2月4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
106
试验地点
2
主要终点
the elastography

研究概览

简要总结

Elastography is a emerging imaging technique that has demonstrated high reliability in the assessment of tissues stiffness and quantification of fibrosis particularly in adult's livers. This ultrasound exploration has no secondary effects. There is no study published in the pediatric population concerning the role of ultrasound elastrography in kidney. The aim of this study is to look for a correlation between the elastography's results and the kidney fibrosis on children who have to undergo a renal biopsy. Elastography may play a potential diagnostic and/or prognostic role in the management of these patients which would limit invasive biopsy procedures.

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
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Male children or feminine from 5 to 18 years old to whom is indicated a renal biopsy by the néphrologue paediatrician whatever is the initial pathology, whatever are one or several current or previous treatments and whatever is their associated comorbidity

排除标准

  • Children of less than 5 years old or more than 18 years
  • Children for whom a draining renal biopsy is not or more indicated by néphrologues
  • Refusal or withdrawal of the consent lit by the holders of the exercise of the parental authority or by the child if he is capable of receiving the information
  • Contraindication in the realization of a draining renal biopsy (current infection, disorder of the coagulation.)

结局指标

主要结局

the elastography

时间窗: 30 months

to study a link enters the elasticity of the kidney estimated by the élastographie and the classification of the renal fibrosis estimated and quantified from the histology by draining renal biopsy.

次要结局

  • The dosage of the créatininémie(30 months)
  • the debit of filtration glomérulaire at the child(30 MONTHS)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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