Cirrhosis Clinical Trial
Official title:
Research on FibroTouch Noninvasive Evaluation of Liver Fibrosis and Cirrhosis
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.
Approximately 600 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.
The liver diseases frequently occur in China. For various reasons, the chronic liver
diseases are not controlled in time, and then develop gradually into liver fibrosis and
cirrhosis. Without effective treatment, the advanced liver cirrhosis seriously influences
the quality of patients' life, and places an intolerable burden on family and society. At
present, the scholars generally thought that the liver fibrosis at early stages is
reversible. Therefore, if the liver fibrosis in patients with chronic liver diseases can be
accurately evaluated at early stages and be treated in time, so we can stop the progress of
diseases and reduce the occurrence of liver cirrhosis and liver cancer.
For many years, liver biopsy is still as "golden standard" for diagnosis of liver
inflammation and fibrosis. However, with its invasiveness, potential risks and some
complications, liver biopsy is limited in clinical application due to the poor acceptability
and repeatability. In recent years, the liver fibrosis cannot directly and accurately
diagnose via the various diagnostic models using serological biomarkers (e.g. FIBROTEST and
APRI) and medical imaging technologies (e.g. ultrasonic B, CT and MRI).
Transient elastography is a new technology in the field of ultrasonic imaging. Liver
stiffness measurement (LSM) is based on the relationship between the speed of spread of
acoustic wave in tissues and stiffness of the tissues. It utilizes specific probes to send
out controlled low-frequency shear waves, the waves signals transmit through liver tissues,
a high-frequency signals will track the transmitting process of shear wave in the liver and
the value of liver stiffness (kPa) is quickly calculated with reference to a built-in liver
histological model, which provides a quantitative standard for diagnosis of liver fibrosis
of chronic liver disease. The bigger LSM value means the faster transmission of shear wave,
and the harder of determined liver tissue.
As stated in the "12th Five-year Plan for Medical Device Technological Industry" (the
Ministry of Science and Technology), China will greatly support the research and development
of new medical devices and promote the application of Chinese transient elastography system,
FibroTouch, which was R&D by Tsing-Hua University independently with new algorithm.
FibroTouch can rapidly determine the LSM in a non-invasive way and provide useful
information for liver fibrosis and steatosis staging.
Due to FibroTouch is a new transient elastography system in marketing, there is no too much
studies on the correlation between FibroTouch and liver biopsy in diagnosis of liver
fibrosis and cirrhosis.
The goal of this prospective and multicenter study is to determine the diagnostic
performance (accuracy, specificity and sensitivity) of FibroTouch for liver fibrosis
assessment in chronic hepatitis B (CHB) patients using ROC analysis, and liver biopsy as the
reference.
Approximately 600 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.
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Observational Model: Cohort, Time Perspective: Prospective
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