Cirrhosis, End Stage Liver Disease, Hepatitis C
Conditions
Keywords
Hepatocellular Carcinoma, Liver Cancer, Ultrasound, Computed Tomography, Alpha fetoprotein, Cirrhosis, Screening, Advanced Liver Disease
Brief summary
The purpose of this study is to determine whether ultrasound or CT scanning is more effective at detecting early liver cancer in patients with advanced liver disease.
Detailed description
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.
Interventions
PROCEDUREScreening
Triphasic CT of the abdomen with and without contrast every 12 months and alpha-fetoprotein testing every 6 months. Repeated until HCC diagnosed for up to 10 years. Ultrasound of the upper left quadrant every 6 months with alpha-fetoprotein testing every 6 months. Repeated until HCC diagnosed for up to 10 years.
Sponsors
Minneapolis Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* liver biopsy or clinical diagnosis compatible with advanced liver fibrosis or cirrhosis * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System) | 6-12 months | Confirmed diagnosis of hepatocellular carcinoma by biopsy or imaging according according to BCLC recommendations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost - Effectiveness of screening measure | 1 year | Cost of each screening protocol to identify one very early/early stage HCC |
Countries
United States
Contacts
Primary ContactChristine Pocha, MD, PhD
Backup ContactKelly A McMaken, MPH
Outcome results
None listed