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Screening for Hepatocellular Carcinoma With Triphasic Helical CT vs. US With Alpha-fetoprotein in Patients With Advanced Liver Disease

18 Years
Open (Enrolling)
Cirrhosis, End Stage Liver Disease, Hepatitis C

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Trial Information

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.

Inclusion Criteria:

- liver biopsy or clinical diagnosis compatible with advanced liver fibrosis or

- potential candidate for treatment of HCC

- imaging study involving the liver in the last 12 months without evidence for HCC

- must be a veteran in VISN 23

Exclusion Criteria:

- active or untreated malignancy other than non-melanoma skin cancer

- patients with advanced medical conditions such as severe cardiovascular disease,
COPD, or severe end-stage liver disease

- patients unable to receive intravenous contrast due to advanced kidney disease or
severe allergy

- history of liver mass identified on imaging study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System)

Outcome Description:

Confirmed diagnosis of hepatocellular carcinoma by biopsy or imaging according according to BCLC recommendations

Outcome Time Frame:

6-12 months

Safety Issue:


Principal Investigator

Christine Pocha, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Minneapolis Veterans Affairs Medical Center


United States: Federal Government

Study ID:




Start Date:

November 2001

Completion Date:

December 2021

Related Keywords:

  • Cirrhosis
  • End Stage Liver Disease
  • Hepatitis C
  • Hepatocellular Carcinoma
  • Liver Cancer
  • Ultrasound
  • Computed Tomography
  • Alpha fetoprotein
  • Cirrhosis
  • Screening
  • Advanced Liver Disease
  • Hepatitis
  • Hepatitis A
  • Hepatitis C
  • Liver Cirrhosis
  • Fibrosis
  • Liver Diseases
  • Liver Neoplasms
  • End Stage Liver Disease
  • Carcinoma, Hepatocellular



Minneapolis Veterans Affairs Medical CenterMinneapolis, Minnesota  55417