This is a multi-center cohort study in which the Real-time Tissue Elastography® measurements will predict prospectively the incidence of hepatocellular carcinoma, the incidence and severity of gastroesophageal varices ascites and decompensated cirrhosis in hepatitis B or C patients.
The aim of this study is to validate the predictive value of Real-time Tissue Elastography® by comparison with serum marker or FibroScan® in chronic hepatitis B or C patients. Every year and for three years, we performed Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy. If in the hospital they can perform FibroScan®, FobroScan® also be performed. Subjects were also performed ultrasonography (US), computed sonography (CT) or magnetic resonance imaging (MRI) evry four or six months. The time between the Real-time Tissue Elastography®, blood sampling, gastrointestinal endoscopy and FiroScan® must not exceed four weeks.
Study Type
OBSERVATIONAL
Enrollment
1,000
Kinki University Faculty of Medicine
Ōsaka-sayama, Osaka, Japan
RECRUITINGCumulative incidence of carcinogenesis of hepatocellular carcinoma
Cumulative incidence of carcinogenesis of hepatocellular carcinoma defined as the time from registration to diagnosis of hepatoceluler carcinomais
Time frame: every four or six months
Cancer-free survival
Cancer-free survival is defined as the time from registration to death due to cencer or any cause
Time frame: every four or six months
Overall survival
Overall survival is defined as the time from registration to death due to any cause
Time frame: one year
The cumulative incidence and severity of gastro-esophageal varices
It is estimated by gastrointestinal scope for every year
Time frame: one year
The cumulative incidence and severity of decompensated cirrhosis
Jaundice, ascites, edema and hepatic encephalopathy etc. is evaluated as decompensated cirrhosis.
Time frame: one year
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