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

Not Applicable

Completed

• Conditions: RENAL FIBROSIS
• Interventions: Procedure: Elastography

• Registration Number: NCT01613625
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-26
• Study Start: 2011-02-04
• Study First Submitted QC: 2012-06-05
• Study First Posted: 2012-06-07
• Primary Completion: 2015-10-13
• Status Verified: 2023-05
• Study Completion: 2023-05-24
• Last Update Submitted: 2023-05-24
• Last Update Posted: 2023-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• 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

Exclusion Criteria

• 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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elastography	Elastography	-

Primary Outcome Measures

Name	Time	Method
the elastography	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.

Secondary Outcome Measures

Name	Time	Method
The dosage of the créatininémie	30 months
the debit of filtration glomérulaire at the child	30 MONTHS

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France