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

Children Clinical Trial

— SHEARWAVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041780
• Other study ID #: P120128
• Status: Completed
• Phase: N/A
• First received: January 20, 2014
• Last updated: September 28, 2016
• Start date: November 2013
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• age < 18 years;

• indication to liver biopsy;

• informed consent of both parents and child if applicable;

• social insurance

Exclusion Criteria:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Children
• Fibrosis
• Liver Cirrhosis
• Liver Fibrosis

Intervention

Procedure:
• Shearwave electrography

Locations

Country	Name	City	State
France	AP-HP, Bicêtre Hospital	Le Kremlin-Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver fibrosis evaluated by the ISHAK score and morphometric evaluation	Histology is the gold standard to evaluate liver fibrosis	up to 1 month	No
Secondary	liver fibrosis evaluation : stiffness using SHEARWAVE elastography		up 1 month	No
Secondary	Liver fibrosis evaluation using Fibrotest (Fibromax)		up 1 month	No