None listed
Conditions
Interventions
Others : Subjects will be randomized by 1:1 ratio into Ultrasonography group and Abbreviated magnetic resonance imaging group. Subjects will be evaluated by 2 rounds of tests with Ultrasonography or A
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 includes any of followings; (1) The identification of splenomegaly on Ultrasonography, CT, or MRI examinations with typical features of liver cirrhosis (2) The identification of esophageal or gastric varices on endoscopic examination 2. Older than 20 years of age 3. Absence of previous or current history of hepatocellular carcinoma within 6 months prior to screening 4. Eastern Cooperative Oncology Group performance status of 0-2 5. Patient is able to comply with scheduled visits, evaluation plans, and other study procedures. 6. Patient is willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Active or suspected cancer other than hepatocellular carcinoma, or a history of malignancy where the risk of recurrence is equal or higher than 20% within 2 years 2. Significant medical comorbidities in which survival is predicted to be less than 3 years 3. Estimated glomerular filtration rate < 30 mL/min/1.73m^2 (1) Estimated glomerular filtration rate by Modification of Diet in Renal Disease equation = 175 × serum creatinine-1.154 × age-0.203 × 1.212 (if black) × 0.742 (if female) 4. Budd-Chiari Syndrome 5. Precautions for MRI (cardiac pacemaker, severe claustrophobia that may interfere with protocol compliance) 6. Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection Rate of patients with early stage hepatocellular carcinoma | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection Rate of patients with very early stage hepatocellular carcinoma;False referral rate of patients with early stage hepatocellular carcinoma;False referral rate of patients with very early stage hepatocellular carcinoma;Detection rate of patients with all-stage hepatocellular carcinoma;False referral rate of patients with very all-stage hepatocellular carcinoma;BCLC stage distribution at initial diagnosis of hepatocellular carcinoma | — |
Countries
Korea, Republic of
Contacts
Public ContactHyo Jung Park
Asan Medical Center
Outcome results
None listed