NCT01350167

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Minneapolis Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis
• End Stage Liver Disease
• Hepatitis C

Interventions

Type	Name	Description
PROCEDURE	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.

Timeline

• Start date: 2001-11-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2011-05-09
• Last updated: 2011-05-24

Locations

1 site across 1 country: United States