At a glance
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Research on FibroTouch Noninvasive Evaluation of Liver Fibrosis and Cirrhosis
In Brief
An observational study evaluating FibroTouch Examination, FibroScan Examination, and 1 other intervention for Liver Fibrosis and 2 related conditions. Completed, enrolled 412 participants across 15 sites.
Detailed Summary
This prospective and multicenter study is to determine the diagnostic performance (accuracy, specificity and sensitivity) of transient elastography (FibroTouch) for liver fibrosis assessment in chronic hepatitis B (CHB) patients using ROC analysis, and liver biopsy as the reference. Actual 517 patients will be enrolled to guarantee 500 final statistical cases; and ≥100 cases are required for fibrosis stage S0/1, S2, S3 and S4 (compensatory stage of cirrhosis), respectively. For each stage, the case is assigned as equally as possible.
Study Details
Timeline
Interventions
Liver stiffness measurements are performed using FibroTouch and the procedure is non-invasive and painless.
Liver stiffness measurements are performed using another transient elastography, FibroScan, and the procedure is non-invasive and painless.
The ultrasonic B examination is made at an empty stomach for ≥8h. The inner diameter of liver, spleen, gallbladder, portal vein and splenoportal vein is measured through the ordinary two-dimensional ultrasonic examination. The echo data of liver surface/edge/parenchyma and gallbladder wall is scored to evaluate the severity of fibrosis.