Biannual Screening for HCC Offered to Patients With Cirrhosis. Introducing Surveillance for Hepatocellular Carcinoma (HCC) in the Central Denmark Region Using Ultrasound and Alpha-Fetoprotein to Reduce HCC-Related Mortality in Patients With Compensated Non-Viral Cirrhosis

Condition(s) studied

Investigational drug(s) / intervention(s)

Ultrasound of the liver and blood sample for alpha-fetoprotein: Ultrasound of the liver without Doppler or contrast. Alpha-fetoprotein ≥20 \* 10\^3 IE/l, doubling since last measurement or two consecutive increasing measurements.

Study summary

This study aims to investigate whether repeated 6-monthly screening for hepatocellular carcinoma (HCC) - called "HCC surveillance" - offered to selected patients with chronic liver disease can reduce HCC-related mortality by facilitating earlier detection of HCC. The screening procedure consists of two tests: an ultrasound examination of the liver and a blood sample to measure alpha-fetoprotein. Patients who screen positive on either examination will be offered standard work-up for HCC, typically beginning with a CT-scan.

In the study HCC surveillance will be offered to all patients with compensated non-viral cirrhosis residing in the Central Denmark Region, one of five administrative regions of Denmark. The study aims to determine the efficacy of HCC surveillance in reducing HCC-related mortality by comparing HCC-related mortality between the Central Denmark Region and the other four Danish regions, where HCC surveillance is not offered.

Eligibility

Primary outcome measure(s)

• HCC-related mortality — From date of inclusion until death due to hepatocellular carcinoma or end of follow-up, assessed up to 30 months
  HCC recorded as the underlying cause of death in the Danish Cause of Death Registry.

Trial sites (6)

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