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

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.

Study Overview

• Status: Completed
• Conditions: RENAL FIBROSIS
• Intervention / Treatment: Procedure: Elastography

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elastography	Procedure: Elastography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
The dosage of the créatininémie	30 months
the debit of filtration glomérulaire at the child	30 MONTHS

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Principal Investigator: alix RUOCCO, Assistance Publique Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2011
• Primary Completion (Actual): October 13, 2015
• Study Completion (Actual): May 24, 2023

Study Registration Dates

• First Submitted: January 26, 2011
• First Submitted That Met QC Criteria: June 5, 2012
• First Posted (Estimated): June 7, 2012

Study Record Updates

• Last Update Posted (Actual): May 25, 2023
• Last Update Submitted That Met QC Criteria: May 24, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis
• Other Study ID Numbers: 2010-A00950-39; 2010-10 (Other Identifier: AP HM)