Screening for Liver Cancer With CT vs. Ultrasound in Patients With Advanced Liver Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cirrhosis, End Stage Liver Disease, Hepatitis C

Intervention / Treatment
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* Procedure: Screening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triphasic CT<br>Triphasic CT of the abdomen with and without contrast every 12 months with alpha-fetoprotein every 6 months. | Procedure: Screening<br>* 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.<br>|
| Active Comparator: Ultrasound<br>Ultrasound of the upper left quadrant with alpha-fetoprotein testing every 6 months. | Procedure: Screening<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost - Effectiveness of screening measure | Cost of each screening protocol to identify one very early/early stage HCC | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Hepatocellular Carcinoma, Liver Cancer, Computed Tomography, Alpha fetoprotein, Cirrhosis, Screening, Advanced Liver Disease