ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B

Supersonic Imagine

Status: Completed

Conditions: Liver Fibrosis

Study type: Observational

Funder types: Industry

Identifiers

NCT02313649

LE2

Details and patient eligibility

About

This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard). The population that will be evaluated are Chinese patients infected with the Hepatitis B virus.

Full description

Hepatitis B is becoming increasingly common. The liver becomes stiffer and this is called fibrosis. A non-invasive method to accurately stage fibrosis is necessary in order to begin the correct treatment. Currently, liver biopsy is used to do this, but there are many disadvantages with this technique.

ShearWave Elastography (SWE), available on the ultrasound machine Aixplorer®, is a non-invasive method to evaluate liver fibrosis.

This study will evaluate how liver stiffness measurements made with SWE correspond with a biopsy result (currently the gold standard).

The sensitivity, specificity, positive predictive value and negative predictive value of liver stiffness measurements with Aixplorer to evaluate the different stages of fibrosis will be analyzed.

Liver stiffness measurement made by the Aixplorer will also be compared to blood markers

Enrollment: 447 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing a liver ultrasound exam due to confirmed Hepatitis B infection ,

• Patients having reached the age of majority in China,

• Patients with a liver biopsy for histological evaluation of liver fibrosis, performed within 3 months after the SWE measurement date, and having the recommended quality criterion:

  • minimal length of biopsy samples of 15 mm, stored in paraffin
  • Minimal number of portal tracts of 6 per biopsy samples

• Patients of Chinese ethnic origin

Exclusion criteria

• Any patient presenting with combined etiologies of chronic liver diseases, including non-Hepatitis B viral infection（Hepatitis A, C, D, E, chronic alcoholic liver disease, hemochromatosis, autoimmune hepatitis, etc)
• History of antiviral therapy at any time
• Any patient presenting with a co-infection of HIV
• Any patient presenting with combined liver malignant tumor
• Previous liver transplantation
• Pregnant women
• Any patient with combined hepatic congestive condition such as Budd Chiari Syndrome, congestive heart failure, chronic constrictive pericarditis...
• Any patient combined with intrahepatic cholestasis