SEAL - Structured Early Assessment of Asymptomatic Liver Fibrosis and Cirrhosis

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00013460
• Date of registration: 04/01/2018
• Prospective Registration: Yes
• Primary sponsor: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz
• Public title: SEAL - Structured Early Assessment of Asymptomatic Liver Fibrosis and Cirrhosis
• Scientific title: SEAL - Structured Early Assessment of Asymptomatic Liver Fibrosis and Cirrhosis - SEAL
• Date of first enrolment: 26/03/2018
• Target sample size: 15855
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00013460
• Study type: observational
• Study design: Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: screening

Countries of recruitment

Germany

Contacts

• Name: Michael Nagel
• Affiliation: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz, I. Medizinische Klinik und Poliklinik

• Name: Anita Arslanow
• Affiliation: UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität MainzI. Medizinische Klinik und Poliklinik

Key inclusion & exclusion criteria

Inclusion criteria: - Member of the statutory health insurer AOK Rhineland-Palatinate/Saarland
- Age = 35 years
- Eligible for check-up 35 health check
- Informed consent

Exclusion criteria: - Not able to give informed consent
- Pregnancy


Age minimum: 35 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

K70.2

K74.6

Primary biliary cirrhosis

Alcoholic cirrhosis of liver

Hepatic sclerosis

K74.0
K74.1
K74.2
K74.3
K74.4
K74.5
K74.6
K70.2
K70.3
K71.7

K74.4

Hepatic fibrosis with hepatic sclerosis

K74.2

Toxic liver disease with fibrosis and cirrhosis of liver

Hepatic fibrosis

K70.3

K74.1

K71.7

Alcoholic fibrosis and sclerosis of liver

Other and unspecified cirrhosis of liver

Biliary cirrhosis, unspecified

K74.5

K74.0

K74.3

Secondary biliary cirrhosis

Intervention(s)

Group 1: Study participants are being screened for elevated liver enzymes ALT and AST. If ALT and/or AST are elevated, liver fibrosis risk is estimated using the AST-/platelet ratio index (APRI). Participants with APRI>0.5 are referred to a gastroenterology specialist for further workup. If liver fibrosis/liver cirrhosis is suspected or diagnosed, patients are being referred to a university liver clinic for confirmation of diagnosis.
Group 2: Historical comparison group of check-up 35 participants and of patients diagnosed with liver fibrosis/liver cirrhosis in the past

Primary Outcome(s)

Primary objective is the number of diagnosis of relevant liver fibrosis or liver cirrhosis by using the SEAL-algorithm per 10.000 check-up 35 health checks in comparison with 10.000 historical check-up 35 health checks.

Secondary Outcome(s)

Secondary objectives:
- prevalence of liver enzyme elevation in the general population
- prevalence of chronic liver disease in the general population
- number needed to screen
- estimation of cost of liver screening
- complications and costs within the initial 3 and 12 months after diagnosis of liver fibrosis and cirrhosis by using the SEAL-algorithm compared to patients diagnosed without liver screening
- estimation of costs saved by early diagnosis

Source(s) of Monetary Support

Innovationsfonds des Gemeinsamen Bundesausschuss (G-BA)

Ethics review

Status: Approved
Approval date: 24/10/2017
Contact:

[e-mail]

Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz

[phone]

[e-mail]

Results

• URL: http://drks.de/search/en/trial/DRKS00013460#studyResults