Screening of Liver Fibrosis in Adults Without Known Liver Disease

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Screening of Liver Fibrosis in Adults Without Known Liver Disease or With Previously Diagnosed Non-alcoholic Fatty Liver Disease

Conditions
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Liver Fibrosis

Intervention / Treatment
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* Diagnostic Test: Transient elastography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Community cohort<br>SIRIUS study team will travel to pre-determined sociomes and perform transient elastography and other examinations | Diagnostic Test: Transient elastography<br>* Both tests belong to the group of non-invasive tests for liver fibrosis (transient elastography belongs to the imaging-based tests and FIB-4 to the blood-based tests)<br>* Other names: FIB-4 score;|
| Outpatient cohort<br>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 | Diagnostic Test: Transient elastography<br>* Both tests belong to the group of non-invasive tests for liver fibrosis (transient elastography belongs to the imaging-based tests and FIB-4 to the blood-based tests)<br>* Other names: FIB-4 score;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver fibrosis | The amount of fibrous tissue in the liver according to non-invasive tests | August, 2022 - to September 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-alcoholic fatty liver disease | The amount of fat in the liver parenchyma by the non-invasive tests CAP and FLI | August, 2022 - September, 2023 | 
| Alcohol associated liver disease | Liver disease plus AUDIT score testimonyijng to the harmful alcohol use | August, 2022 - September, 2023 | 
| Body mass index | As calculated from height and weight (together with waist-to-hip ratio) | August, 2022 - September, 2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Non-alcoholic fatty liver disease, Liver fibrosis, Alcohol associated liver disease