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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of carcinogenesis of hepatocellular carcinoma | Cumulative incidence of carcinogenesis of hepatocellular carcinoma defined as the time from registration to diagnosis of hepatoceluler carcinomais | every four or six months |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer-free survival | Cancer-free survival is defined as the time from registration to death due to cencer or any cause | every four or six months |
| Overall survival | Overall survival is defined as the time from registration to death due to any cause |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with chronic hepatitis B or C will be eligible for the study. Subjects with other infectious viral diseases or chronic liver disease are excluded for study enrollment.
Real-time Tissue Elastography®, serum maker and gastrointestinal endoscopy are performed. If in the hopsital they can perform FibroScan®, FobroScan® also be performed.
The time between the Real-time Tissue Elastography®, blood sampling, FiroScan® must not exceed four weeks.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Norihisa Yada, M.D. | Contact | +81-72-366-0221 | 3525 | yada@med.kindai.ac.jp |
| Kazuomi Ueshima, M.D. | Contact | +81-72-366-0221 | 3525 | kaz-ues@med.kindi.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Masatoshi Kudo, Professor | Kinki University Faculty of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinki University Faculty of Medicine | Recruiting | Ōsaka-sayama | Osaka | 589-8511 | Japan |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D019698 | Hepatitis C, Chronic |
| D006509 | Hepatitis B |
| D006526 | Hepatitis C |
| D006521 | Hepatitis, Chronic |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| one year |
| The cumulative incidence and severity of gastro-esophageal varices | It is estimated by gastrointestinal scope for every year | one year |
| The cumulative incidence and severity of decompensated cirrhosis | Jaundice, ascites, edema and hepatic encephalopathy etc. is evaluated as decompensated cirrhosis. | one year |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D005355 | Fibrosis |