An observational study in Liver Fibrosis, sponsored by SuperSonic Imagine. Completed at 15 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-19.
Sponsored by SuperSonic Imagine · Observational
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.
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
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's enrollment of 447 is above the median of 390 across 407 observational studies indexed under Hepatitis B.
Browse Hepatitis B studies →SuperSonic Imagine is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Chinese patients with chronic viral hepatitis B admitted for the realization of an intercostal liver biopsy in defined investigator centers.
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:
Exclusion Criteria:
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).
This will be determined by histological examination of liver biopsy
Time frame: Within 12 months of the study start date
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).
This will be determined by histological examination of liver biopsy
Time frame: Within 12 months of the study start date
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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