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Non Invasive Assessment of Liver Fibrosis in Children: Comparison of ShearWave Elastography, Fibrotest and Liver Biopsy (SHEARWAVE)

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ClinicalTrials.gov Identifier: NCT02041780
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The purpose of this study is to determine if SWE and Fibrotest®/ Fibromax®, alone or associated, are effective methods to assess liver fibrosis in children.

Condition or disease Intervention/treatment Phase
Liver Fibrosis Children Procedure: Shearwave electrography Not Applicable

Detailed Description:
Liver biopsy will be the gold standard to assess fibrosis using Ishak score and morphometric evaluation of fibrosis. All children included will have a measure of liver stiffness using SWE with 5 measures performed in the area where the biopsy is performed and 5 measures in an other place in the liver. Fibrotest®/ Fibromax® will be performed on blood sample. All exams will be done within 1 month. diagnostic performance of SWE and Fibrotest®/ Fibromax® will be assessed respectively. algorithm using the results of both technics will be tested in order to test diagnostic performance and to obtain better performances.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non Invasive Assessment of Liver Fibrosis in Children: Evaluation of Diagnostic Performances of ShearWave Elastography (SWE) and Fibrotest®/ Fibromax® by Comparison With Fibrosis Score on Liver Biopsy
Study Start Date : November 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Shearwave electrography

Two experimental interventions will be realized in each patient in this population : Shearwave electrography (new diagnostic test of fibrosis) and Fibrotest .

Moreover, liver biopsies, the gold standard for the fibrosis diagnosis is also realized in each patient within usual cares.

Procedure: Shearwave electrography



Primary Outcome Measures :
  1. liver fibrosis evaluated by the ISHAK score and morphometric evaluation [ Time Frame: up to 1 month ]
    Histology is the gold standard to evaluate liver fibrosis


Secondary Outcome Measures :
  1. liver fibrosis evaluation : stiffness using SHEARWAVE elastography [ Time Frame: up 1 month ]
  2. Liver fibrosis evaluation using Fibrotest (Fibromax) [ Time Frame: up 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age < 18 years;
  • indication to liver biopsy;
  • informed consent of both parents and child if applicable;
  • social insurance

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041780


Locations
France
AP-HP, Bicêtre Hospital
Le Kremlin-Bicêtre, France, 94275
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Stéphanie FRANCHI-ABELA, MD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02041780     History of Changes
Other Study ID Numbers: P120128
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Diagnostic
Liver fibrosis
Ishak score
Fibrotest
ShearWave elastography
Liver biopsies

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics