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Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis

Not Applicable
Recruiting
Conditions
Diseases of the digestive system
Registration Number
KCT0001739
Lead Sponsor
The Catholic University of Korea
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
211
Inclusion Criteria

Male or female subject between 20 and 70 years of age at the enrollment
Has chronic liver disease
Fulfill below conditions A and B

A.The evidence of cirrhosis of any etiology within 12 months prior to screening Definition of cirrhosis by any of following methods
1) Histologically by liver biopsy;
2) Non-histologically by evidence of portal hypertension in the presence of chronic liver disease;
- Evidence of portal hypertension, including any of followings;
>The identification of splenomegaly on ultrasonography, CT, or MRI examinations with typical features of cirrhosis
>The identification of esophageal or gastric varices on endoscopic examination

B. Risk Index more than 2.33 ; Risk Index = 1.65 (if PT% is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100x10(3)/mm3) + 0.74 (if the presence of HCV is positive).

Exclusion Criteria

Presence of liver cancer or other malignancy
No liver cirrhosis
pregnant or breast-feeding

Study & Design

Study Type
Observational Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Sensitivity
Secondary Outcome Measures
NameTimeMethod
False referral rate
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