Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography

• Conditions: Chronic Hepatitis B; Chronic Hepatitis C

• Registration Number: NCT01360892
• Lead Sponsor: Kindai University

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2010-08
• Study Start: 2010-09
• Study First Submitted: 2011-05-21
• Study First Submitted QC: 2011-05-24
• Last Update Submitted: 2011-05-24
• Study First Posted: 2011-05-26
• Last Update Posted: 2011-05-26
• Primary Completion: 2013-08
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Male or female and at least 20 years of age
• Chronic hepatitis B or Chronic hepatitis C

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Exclusion Criteria

• Evidence or history of hepatocellular carcinoma
• History of alcohol abuse (alcohol intake > 20g/day)
• Pregnant or lactating patients
• Psychosis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of carcinogenesis of hepatocellular carcinoma	every four or six months	Cumulative incidence of carcinogenesis of hepatocellular carcinoma defined as the time from registration to diagnosis of hepatoceluler carcinomais

Secondary Outcome Measures

Name	Time	Method
Cancer-free survival	every four or six months	Cancer-free survival is defined as the time from registration to death due to cencer or any cause
Overall survival	one year	Overall survival is defined as the time from registration to death due to any cause
The cumulative incidence and severity of gastro-esophageal varices	one year	It is estimated by gastrointestinal scope for every year
The cumulative incidence and severity of decompensated cirrhosis	one year	Jaundice, ascites, edema and hepatic encephalopathy etc. is evaluated as decompensated cirrhosis.

Trial Locations

Locations (1)

Kinki University Faculty of Medicine; 🇯🇵 Osaka-sayama, Osaka, Japan