This is a multi-center cross-sectional study in which the Real-time Tissue Elastography® measurements will be collected prospectively from patients with chronic hepatitis B or C virus presenting for liver biopsy.
The aim of this study is to validate the diagnostic value of Real-time Tissue Elastography® by comparison with liver histology, serum marker or FibroScan® in chronic hepatitis B or C patients.Real-time Tissue Elastography®, biopsy and serum maker are performed. If in the hospital they can perform FibroScan®, FobroScan® also be performed. The subjects must be scheduled for liver biopsy either prior to treatment (treatment naïve) or, if previously treated, they must have been off treatment for at least six months. The time between the Real-time Tissue Elastography® , biopsy, blood sampling and FiroScan® must not exceed four weeks.
Study Type
OBSERVATIONAL
Enrollment
500
Kinki University Faculty of Medicine
Ōsaka-sayama, Osaka, Japan
RECRUITINGCorrelative evaluation with liver fibrosis by Real-time Tissue Elastography® and histological diagnosis
To evaluate the correlation between Real-time Tissue Elastography® index and histological diagnosis (the gold standard for liver fibrosis), we calculate sensitivity and specificity, ROC curves. Sensitivity, specificity and ROC curves obtained under below stiations: 1. liver fibrosis index diagnose of histological diagnosis F4 2. liver fibrosis index diagnose of histological diagnosis F3 or greater 3. liver fibrosis index diagnose of histological diagnosis F2 or greater
Time frame: one year
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and serum maker
To evaluate the correlation between Real-time Tissue Elastography® index and serum markers of hepatic fibrosis, we estimate Pearson correlation coefficient of each request.
Time frame: one year
Correlative evaluation with liver fibrosis by Real-time Tissue Elastography® and FibroScan®
To evaluate the correlation between Real-time Tissue Elastography® index and FibroScan® index, we estimate Pearson correlation coefficient of each request.
Time frame: one year
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