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

Question Most patients with liver cirrhosis are detected at a late stage of their disease. In approximately 75 %, diagnosis is based on the development of complications such as ascites or bleeding. At this stage causative treatment interventions are less successful or impossible. Screening for liver health and disease is not included in standard medical check-up programs.

Methods As part of the SEAL program, 16,000 insured persons from a large German health insurance company (AOK) will be offered additional testing of liver enzymes as part of a nationwide primary care program (check-up 35) in two German states, i.e. Rhineland-Palatinate and Saarland. In case of elevated transaminases, the APRI score as a liver fibrosis risk score 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 are referred to a liver center for further hepatologic workup. Endpoints include data on the epidemiology of elevated liver enzymes, cost-benefit assessments and prevalence of liver fibrosis in a general population.

Results To date, more than 10 000 patients have been enrolled in the SEAL program. The average age of female and male patients was 64 years and 62 years. Of the examined patients, 11 % and 7 % presented with increased ALT and AST values with a maximum of 1.050 U/l and 434 U/l, respectively. In 470 patients a known liver disease was already present at inclusion. Nevertheless, 5 % and 6 % of patients without known liver disease had pathologically elevated ALT and AST, respectively.

Conclusions The establishment of an early diagnosis of liver disease is controversially discussed by professionals and in the literature. The initial data indicates that a relevant group of the population suffers from an increase in transaminases. The SEAL project will provide further data on feasibility, effectiveness and cost-benefit assessment in the German health care system and will contribute substantial evidence to the meaningfulness of such a measure.

Publication History

Article published online:
04 January 2021