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

RENAL FIBROSIS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613625
• Other study ID #: 2010-A00950-39
• Secondary ID: 2010-10
• Status: Completed
• Phase: N/A
• Start date: February 4, 2011
• Est. completion date: May 24, 2023

Study information

• Verified date: May 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 24, 2023
• Est. primary completion date: October 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Fibrosis
• RENAL FIBROSIS

Intervention

Procedure:
• Elastography

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the elastography	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.	30 months
Secondary	The dosage of the créatininémie		30 months
Secondary	the debit of filtration glomérulaire at the child		30 MONTHS