German Clinical Trials Register

Acronym/abbreviation of the study

SEAL

URL of the study

http://www.lebervorsorge.de

Brief summary in lay language

Liver cirrhosis is a chronic condition which develops over the course of years and decades as result of several underlying diseases. Most common etiologies include alcohol disorder, chronic hepatitis B- and hepatitis C-infection as well as non-alcoholic steatohepatitis (NASH) associated with metabolic syndrome, other causes are autoimmune liver disease or other metabolic diseases. Although liver cirrhosis develops over the course of decades it is diagnosed in an early compensated state in only 25% of patients. Late diagnosis is common, typically complications of liver cirrhosis result in diagnosis of the disease. Patients with decompensated liver cirrhosis carry a high risk of subsequent complications and death. Mean life expectancy is shortened by 10 to 20 years. In many cases treatment of the underlying liver disease could prolong progression of liver fibrosis and cirrhosis and therefore has the potential to prevent liver cirrhosis complications. However, no algorithm for early identification of patients with liver fibrosis and cirrhosis has been established, and in Germany screening for elevated liver enzymes is not part of the established preventive check-up exam within the statutory health insurance system. The SEAL study examines if screening for elevated liver enzymes as part of a check-up exam has the potential to improve early diagnosis of liver fibrosis and liver cirrhosis in the general population. Within the study 16.000 participants of a health care check-up will be screened for elevations of alanin-aminotransferase (ALT) and asparate-aminotransferase (AST). If ALT and/or AST are elevated, the AST-/platelet-ratio index (APRI) is being calculated which is a tool to evaluate risk of liver fibrosis. Participants with an APRI>0.5 are being referred to a gastroenterology specialist for further liver workup. If liver fibrosis/liver cirrhosis is suspected after workup, participants are referred to a liver- and liver transplant-unit for final confirmation, e.g. by additional laboratory workup, elastography and liver biopsy, and specific therapy of chronic liver disease. Objectives of the study are the number of patients with newly established diagnosis of liver fibrosis and liver cirrhosis, the prevalence of liver enzyme elevation and chronic liver disease in the general population as well as an health economics assessment of cost-benefit.

Brief summary in scientific language

Although liver cirrhosis develops over the course of decades it is diagnosed in an early compensated state in only 25% of patients. Late diagnosis is common, typically complications of liver cirrhosis result in diagnosis of the disease. Patients with decompensated liver cirrhosis carry a high risk of subsequent complications and death. Mean life expectancy is shortened by 10 to 20 years. In many cases treatment of the underlying liver disease could prolong progression of liver fibrosis and cirrhosis and therefore has the potential to prevent liver cirrhosis complications. However, no algorithm for early identification of patients with liver fibrosis and cirrhosis has been established, and in Germany screening for elevated liver enzymes is not part of the established preventive check-up exam within the statutory health insurance system. The SEAL study examines if screening for elevated liver enzymes as part of a check-up exam has the potential to improve early diagnosis of liver fibrosis and liver cirrhosis in the general population. Within the study 16.000 participants of a health care check-up will be screened for elevations of alanin-aminotransferase (ALT) and asparate-aminotransferase (AST). If ALT and/or AST are elevated, the AST-/platelet-ratio index (APRI) is being calculated which is a tool to evaluate risk of liver fibrosis. Participants with an APRI>0.5 are being referred to a gastroenterology specialist for further liver workup. If liver fibrosis/liver cirrhosis is suspected after workup, participants are referred to a liver- and liver transplant-unit for final confirmation, e.g. by additional laboratory workup, elastography and liver biopsy, and specific therapy of chronic liver disease. Objectives of the study are the number of patients with newly established diagnosis of liver fibrosis and liver cirrhosis, the prevalence of liver enzyme elevation and chronic liver disease in the general population as well as an health economics assessment of cost-benefit.