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Completed

NCT Number: NCT02181452

Liver Fibrosis Assessment With ShearWave Elastography

Chronic liver disease/fibrosis can be the result of various causes, and the result is that the liver tissue becomes stiff. ShearWave™ elastography, available on the Aixplorer® ultrasound system, is a method that can be used to measure the stiffness of organs in the body, for example the liver.

This study will evaluate how this technology performs as a non-invasive test to stage liver fibrosis in patients with chronic liver disease.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Antwerp, Edegem, Belgium

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About this study

The measurements of liver stiffness made by the Aixplorer® will be compared to (where available) :

  • blood markers
  • biopsy results
  • other stiffness measurement exams (FibroScan, ARFI, ElastPQ...)

The influence of other (confounding) factors on the reliability of SWE measurements will be analyzed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients meeting a single condition below:
  • Chronic hepatitis B, defined by serology HBsAg positive and the presence of DNA / RNA in the serum, or
  • Chronic hepatitis C, defined by serology anti-HCV positive and the presence of DNA / RNA in the serum, or
  • non-alcoholic fatty-liver disease
  • And meeting all of the conditions below:
  • liver biopsy for histological evaluation of liver fibrosis
  • Length of liver biopsy ≥ 15 mm paraffin sections (except if cirrhosis)
  • Age of majority in their country
  • Obtaining the signature of consent for participation in the data collection, in addition to the routine consent form routinely used at the sites.

Exclusion criteria

  • Cause of chronic liver disease other than viral (alcohol, hemochromatosis, autoimmune hepatitis, biliary tract disease intrahepatic...) and other than non-alcoholic fatty-liver disease
  • History of antiviral therapy for 6 months or less of current antiviral therapy
  • Any systemic, viral hepatitis and HIV co-infection
  • Pregnant woman
  • Failure to obtain consent
  • Length of all liver biopsy specimens below 15mm

Treatment and study plan

Primary outcomes

  1. Correlation coefficients between factors and liver stiffness

    Time frame: Within one year of the study start date

    Factors include patient's clinical and biological parameters

Secondary outcomes

  1. Technical success rates depending on factors

    Time frame: Within one year of the study start date

    Factors include patient's clinical and biological parameters

  2. Diagnostic performance of multivariate models to assess liver fibrosis levels

    Time frame: Within one year of the study start date

    Determined by histological examination of liver biopsy. The resulting tests will be compared on the basis of their AUROC and test of statistical differences.

    Fibrosis levels involved are:

    • at least significant fibrosis (Metavir score F≥2)
    • at least severe fibrosis (Metavir score F≥3)
    • liver cirrhosis (Metavir score F=4)

  3. Sensitivity, specificity, positive and negative predictive values of the best multivariate model to assess liver fibrosis

    Time frame: Within one year of the study start date

    This will be determined by histological examination of liver biopsy

Sponsors and collaborators

Lead sponsor

SuperSonic Imagine

Industry

Collaborators

  • Johann Wolfgang Goethe University Hospital

Registry information

Official study title

Evaluation of SWE Performances for the Non-Invasive Diagnosis of Liver Fibrosis in Patients With Chronic Liver Diseases

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 4, 2014
Registry last updated
May 12, 2015

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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