RecruitingNot ApplicableNCT07469319

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

Introducing HCC Surveillance in the Central Denmark Region


Sponsor

University of Aarhus

Enrollment

617 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 79 Years

Inclusion Criteria8

  • Cirrhosis
  • No history of chronic hepatitis B or C
  • Compensated cirrhosis defined as:
  • No recent variceal bleeding, no uncontrolled ascites, no clinically apparent hepatic encephalopathy, and Child-Pugh score ≤ 8
  • Age 40-79 years
  • Expected remaining life expectancy ≥ 1 year
  • Not already in follow-up after treatment for HCC
  • No clinical suspicion of HCC

Exclusion Criteria1

  • \-

Interventions

DIAGNOSTIC_TESTUltrasound 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.


Locations(6)

Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Regional Hospital Gødstrup

Herning, Central Jutland, Denmark

Horsens Regional Hospital

Horsens, Central Jutland, Denmark

Randers Regional Hospital

Randers, Central Jutland, Denmark

Silkeborg Regional Hospital

Silkeborg, Central Jutland, Denmark

Viborg Regional Hospital

Viborg, Central Jutland, Denmark

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NCT07469319


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