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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound of the liver and blood sample for alpha-fetoprotein.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma (HCC), Cirrhosis. Basic parameters: 40 years — 79 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Introducing HCC Surveillance in the Central Denmark Region
Overview
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.
Detailed description
Primary liver cancer is the sixth most common cancer and the third leading cause of cancer-related death. Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and often develops in patients with chronic liver disease (cirrhosis), who have a substantially increased risk of HCC.
Because of this high risk, repeated screening for HCC, commonly referred to as HCC surveillance, is recommended by all major international liver societies. The hope is to identify HCC while curative treatment is still possible. In Denmark, HCC surveillance is only recommended for patients with cirrhosis caused by chronic viral hepatitis. Currently, it is not recommended to other patients with cirrhosis due to these patients' low risk of HCC and the lack of randomized studies to determine the efficacy of HCC surveillance as a means to reduce HCC-related or all-cause mortality.
On the study HCC surveillance is introduced for patients with compensated non-viral cirrhosis in the Central Denmark Region, one of Denmark's five administrative regions. Screening will consist of biannual abdominal ultrasound combined with alpha-fetoprotein (AFP) testing. Patients who screen positive will be offered standard work-up for HCC. 600 patients are expected to be enrolled and they will be offered three rounds of screening at 0, 6 months, and 12 months, i.e., there is no individual-level randomization in this study. Instead, national registry data will be used to compare HCC-related mortality (the primary outcome) and HCC incidence and other secondary outcomes between the Central Denmark Region and the other four Danish regions where HCC surveillance is not offered.
Interventions
- Diagnostic test 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.
Primary outcome measures
- HCC-related mortality [Time frame: From date of inclusion until death due to hepatocellular carcinoma or end of follow-up, assessed up to 30 months]
Secondary outcome measures (4)
- HCC incidence [Time frame: From date of inclusion until diagnosis of hepatocellular carcinoma or end of follow-up, assessed up to 30 months.]
- All-cause mortality [Time frame: From date of first screening to first occurrence of death from any cause assessed up to 30 months.]
- Use of diagnostic tests [Time frame: From date of inclusion to first occurrence of death from any cause or diagnosis of hepatocellular carcinoma, assessed up to 30 months.]
- HCC-related mortality (sensitivity analysis) [Time frame: From date of first screening to first occurrence of death from hepatocellular carcinoma, assessed up to 30 months.]
Eligibility criteria
Inclusion criteria
- 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 criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Denmark · 6 centers
- Aarhus University Hospital — Aarhus
- Regional Hospital Gødstrup — Herning
- Horsens Regional Hospital — Horsens
- Randers Regional Hospital — Randers
- Silkeborg Regional Hospital — Silkeborg
- Viborg Regional Hospital — Viborg
Identifiers
NCT: NCT07469319 · 1-10-72-55-25