Screening for Hepatocellular Carcinoma With Triphasic Helical CT vs. US With Alpha-fetoprotein in Patients With Advanced Liver Disease
Most cases of hepatocellular carcinoma (HCC) arise in patients with advanced liver disease,
usually cirrhosis. Most patients with clinically evident HCC are not candidates for
treatment with curative intent because of large tumor size, invasion of hepatic or portal
veins, or metastatic disease. For this reason, screening for HCC at an asymptomatic and
potentially curable stage in patients with advanced liver disease has been recommended by
some authorities. Screening with various methods, of which ultrasound (US) and
alpha-fetoprotein (AFP) have been the most extensively studied, has become accepted
practice. Recently the technique of imaging the liver with or during both the hepatic
arterial and portal venous phases of intravenous contrast ("liver-shuttle") has shown
increased sensitivity in detecting HCCs compared to US.
The hypothesis of this study is that CT using a "liver-shuttle" protocol once a year is more
sensitive and specific than US twice a year, both in combination with AFP for identification
of potentially curable HCC in patients with cirrhosis. Patients will be randomized to
"routine," accepted screening with hepatic US and AFP testing every 6 months or AFP testing
every 6 months wtih triphasic CT every 12 months.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System)
Confirmed diagnosis of hepatocellular carcinoma by biopsy or imaging according according to BCLC recommendations
6-12 months
No
Christine Pocha, MD, PhD
Principal Investigator
Minneapolis Veterans Affairs Medical Center
United States: Federal Government
3034-A
NCT01350167
November 2001
December 2021
Name | Location |
---|---|
Minneapolis Veterans Affairs Medical Center | Minneapolis, Minnesota 55417 |