Liver Fibrosis Assessment With ShearWave Elastography

Supersonic Imagine

Status: Completed

Conditions: Liver Fibrosis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02181452

LE1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,333 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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