Screening of Liver Fibrosis in Adults Without Known Liver Disease (SIRIUS)

F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica

Status: Not yet enrolling

Conditions: Liver Fibrosis

Treatments: Diagnostic Test: Transient elastography

Study type: Observational

Funder types: Other

Identifiers

NCT05486767

SIRIUS

Details and patient eligibility

About

SIRIUS is the "serious" response to the prevalence of liver cirrhosis in Slovakia. We plan to screen adult Slovaks without acute or life-threatening comorbidity and without known liver disease (except from non-alcoholic fatty liver disease) for liver fibrosis by transient elastography (in community) or FIB-4 score (in outpatient clinics).

Full description

According to the Lancet Gastroenterology and Hepatology, Slovakia ranks at the top of the prevalence of liver cirrhosis in the world. Moreover, liver diseases are the leading cause of death in the age-group of 25 - 50 years-old. SIRIUS is the response conceived by the governing board of the Slovak society of hepatology with two main aims: to screen for liver fibrosis and to spread the largely unknown information in community, and primary-care sector.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adult, written informed consent

Exclusion criteria

• unable to provide sufficient reliable information for any reason
• withdrawal of the consent, anytime
• acute illness (e.g. febrile, drunk, on antibiotics, trauma, myocardial infarction < 2 months, operated on < 2 months, other)
• chronic disease interfering with the endpoint (malignancy < 2 years; decompensated chronic disease such as chronic heart disease with dyspnea New York heart Association NYHA 2+, Chronic obstructive pulmonary disease COPD GOLD B+, other)
• chronic liver disease other than non-alcoholic fatty liver disease without previous diagnosis of fibrosis

Trial design

1,000 participants in 2 patient groups

Community cohort

Description:

SIRIUS study team will travel to pre-determined sociomes and perform transient elastography and other examinations

Treatment:

Diagnostic Test: Transient elastography

Outpatient cohort

Description:

Patients recruited during the elective / preventive examinations at the primary-care clinics or at other outpatient-clinics will have performed Hep-calculator for FIB-4 w/wo transient elastography

Treatment:

Diagnostic Test: Transient elastography