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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2021-12-31

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.

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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.

Conditions

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Cirrhosis End Stage Liver Disease Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Triphasic CT

Triphasic CT of the abdomen with and without contrast every 12 months with alpha-fetoprotein every 6 months.

Group Type ACTIVE_COMPARATOR

Screening

Intervention Type PROCEDURE

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.

Ultrasound

Ultrasound of the upper left quadrant with alpha-fetoprotein testing every 6 months.

Group Type ACTIVE_COMPARATOR

Screening

Intervention Type PROCEDURE

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.

Interventions

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Screening

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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No