Liver Fibrosis
Conditions
Keywords
Liver fibrosis, Screening, Non-alcoholic fatty liver disease, Alcohol associated liver disease
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTTransient elastography
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)
Sponsors
University Hospital Bratislava
University Hospital Kosice
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver fibrosis | August, 2022 - to September 2023 | The amount of fibrous tissue in the liver according to non-invasive tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-alcoholic fatty liver disease | August, 2022 - September, 2023 | The amount of fat in the liver parenchyma by the non-invasive tests CAP and FLI |
| Alcohol associated liver disease | August, 2022 - September, 2023 | Liver disease plus AUDIT score testimonyijng to the harmful alcohol use |
| Body mass index | August, 2022 - September, 2023 | As calculated from height and weight (together with waist-to-hip ratio) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome dysbiosis | August, 2022 - September, 2023 | Dysbiosis will be determined based on the alpha and beta diversity, followed by a the taxonomic analysis |
Countries
Slovakia
Contacts
Primary ContactĽubomír Skladaný, MD, PhD
Backup ContactSvetlana Dr Adamcová Selčanová, MD, PhD
Outcome results
None listed