SEAL program – Early detection of liver fibrosis and cirrhosis by screening of the general population

Background:

Most patients with liver cirrhosis are detected at late stages of their disease. In approximately 75% of cases diagnosis is based on the development of complications such as ascites or bleeding. At this stage causative treatment is less successful or impossible. Screening for liver health and disease is not included in standard medical check-up programs. The SEAL program (Structured Early Detection of Asymptomatic Liver Cirrhosis) investigates the feasibility, effectiveness and cost-benefit assessment of a general screening program for liver fibrosis and cirrhosis.

Method:

As part of the G-BA-funded SEAL program, 16,000 insured persons from a large German health insurance company (AOK) are offered additional testing of liver enzymes as part of the nationwide primary care program (check-up 35) in two German states, i.e. Rhineland-Palatinate and Saarland. In case of elevated serum aminotransferase activities, the APRI score as a liver fibrosis risk marker is calculated. If the APRI score is suggestive for liver disease, patients are referred to a gastroenterologist for further differential diagnostic assessment. Patients suspected to have relevant liver fibrosis present at an academic medical center for further workup. Endpoints include data on the epidemiology of elevated liver enzymes, cost-benefit assessments and prevalence rates of liver fibrosis in the general population.

Results:

To date, more than 7.000 patients have been enrolled in the SEAL program. The average age of female and male patients was 64 years and 62 years, respectively. Of the examined patients, 11% and 6% presented with increased ALT and AST activities with a maximum of 1.050 U/l and 434 U/l, respectively. In 499 patients, known liver disease was present at inclusion. Nevertheless, 11% and 5% of patients without known liver disease presented with significantly elevated ALT and/or AST activities, triggering further dedicated examinations by liver experts.

Conclusions:

The establishment of an early diagnosis of liver diseases is controversially discussed by professionals and in the literature. SEAL data already indicate that a relevant group of the population presents with increased aminotransferases but no diagnosis of chronic liver disease. The SEAL project will provide data on feasibility, effectiveness and cost-benefit assessment in our health care system and provide evidence for the implementation of such a screening measure.