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

Evaluation of ShearWave™ Elastography Performances for the Non-Invasive Assessment of Liver Fibrosis in Chinese Patients With Chronic Hepatitis B Infection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02313649

Enrollment

447

Registered

2014-12-10

Start date

2014-12-31

Completion date

2016-04-30

Last updated

2016-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Fibrosis

Keywords

liver, fibrosis, elastography, ShearWave Elastography, ultrasound

Brief summary

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.

Detailed 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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Areas under the ROC curves for the ability of SWE measurements to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4).	Within 12 months of the study start date	This will be determined by histological examination of liver biopsy

Secondary

Measure	Time frame	Description
Sensitivity, specificity, positive and negative predictive values of SWE to predict at least significant fibrosis (Metavir F≥2), at least severe fibrosis (Metavir F≥3), and liver cirrhosis (Metavir F=4).	Within 12 months of the study start date	This will be determined by histological examination of liver biopsy

Countries

China

Outcome results