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Completed

NCT Number: NCT02041780

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

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.

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Key information

Conditions

Liver Fibrosis Children Digestive System Diseases Disease Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Shearwave electrography

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: SHEARWAVE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 22, 2014
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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