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

NCT ID: NCT01360892

Last Updated: 2011-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Hepatitis B Chronic Hepatitis C

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Evidence or history of hepatocellular carcinoma
* History of alcohol abuse (alcohol intake \> 20g/day)
* Pregnant or lactating patients
* Psychosis
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kindai University

OTHER

Sponsor Role lead

Responsible Party

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Department of Gastroenterology and Hepatology, Kinki University Faculty of Medicine

Principal Investigators

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Masatoshi Kudo, Professor

Role: STUDY_CHAIR

Kinki University Faculty of Medicine

Locations

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Kinki University Faculty of Medicine

Ōsaka-sayama, Osaka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Norihisa Yada, M.D.

Role: CONTACT

+81-72-366-0221 ext. 3525

Kazuomi Ueshima, M.D.

Role: CONTACT

+81-72-366-0221 ext. 3525

Facility Contacts

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Norihisa Yada, M.D.

Role: primary

+81-72-366-0221 ext. 3525

Kazuomi Ueshima, M.D.

Role: backup

+81-72-366-0221 ext. 3525

Other Identifiers

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JLOG1003

Identifier Type: -

Identifier Source: org_study_id

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