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

Prediction of Incidence of Liver Cancer or PorTal Hypertension in Patients With Viral Hepatitis by Use of Real-time Tissue Elastography

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01360892

Acronym

PICTURE

Enrollment

1000

Registered

2011-05-26

Start date

2010-09-30

Completion date

2013-09-30

Last updated

2011-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B, Chronic Hepatitis C

Keywords

Hepatitis B virus, Hepatitis C virus, Chronic hepatitis, Liver chlorosis, Liver stiffness, Liver fibrosis

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Japan

Contacts

Primary ContactNorihisa Yada, M.D.

yada@med.kindai.ac.jp+81-72-366-0221

Backup ContactKazuomi Ueshima, M.D.

kaz-ues@med.kindi.ac.jp+81-72-366-0221

Outcome results