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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01613625
First received: January 26, 2011
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
RENAL FIBROSIS
Procedure: Elastography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Interest Of Renal Elastography In Children As A Diagnostic Tool Of Renal Fibrosis: Confrontation To Histological Features Of Renal Biopsies

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • the elastography [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    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:
  • The dosage of the créatininémie [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • the debit of filtration glomérulaire at the child [ Time Frame: 30 MONTHS ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elastography Procedure: Elastography

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01613625

Locations
France
Assistance Publique Hopitaux de Marseille
Marseille, France, 13354
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: alix RUOCCO Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01613625     History of Changes
Other Study ID Numbers: 2010-A00950-39, 2010-10
Study First Received: January 26, 2011
Last Updated: August 28, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014