Clinical trial NCT01350167: Screening for Liver Cancer With CT vs. Ultrasound in Patients With Advanced Liver Disease
Official title: Screening for Hepatocellular Carcinoma With Triphasic Helical CT vs. US With Alpha-fetoprotein in Patients With Advanced Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhosis
End Stage Liver Disease
Hepatitis C
Keywords: Hepatocellular Carcinoma
Liver Cancer
Ultrasound
Computed Tomography
Alpha fetoprotein
Cirrhosis
Screening
Advanced Liver Disease
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2011-05-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of screening measure to detect very early/early stage HCC (Barcelona Clinic Liver Cancer Staging System)
timeFrame: 6-12 months
Secondary outcomes:
measure: Cost - Effectiveness of screening measure
timeFrame: 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Veterans Affairs Medical Center
state: Minnesota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Christine Pocha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pocha C, Dieperink E, McMaken KA, Knott A, Thuras P, Ho SB. Surveillance for hepatocellular cancer with ultrasonography vs. computed tomography -- a randomised study. Aliment Pharmacol Ther. 2013 Aug;38(3):303-12. doi: 10.1111/apt.12370. Epub 2013 Jun 10.