Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University Hospital Bratislava | OTHER |
| University Hospital Kosice | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community cohort | SIRIUS study team will travel to pre-determined sociomes and perform transient elastography and other examinations |
| |
| Outpatient cohort | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transient elastography | Diagnostic Test | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Liver fibrosis | The amount of fibrous tissue in the liver according to non-invasive tests | August, 2022 - to September 2023 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome dysbiosis | Dysbiosis will be determined based on the alpha and beta diversity, followed by a the taxonomic analysis | August, 2022 - September, 2023 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
We will approach adults of any ethnicity and gender in a stable health-status without any diseases or with a chronic extra-hepatic disease/diseases which are at the time of exam compensated and under control for more than 2 months; any medication is acceptable. Primarily, we are interested in patients without any known history of registered liver disease, but patients with steatosis without known fibrosis or cirrhosis will be enrolled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ľubomír Skladaný, MD, PhD | Contact | 905482997 | lubomir.skladany@gmail.com | |
| Svetlana Dr Adamcová Selčanová, MD, PhD | Contact | sselcanova@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Peter Jarčuška, Prof | University Hospital Košice | Study Chair |
| Martin Janičko, MD, PhD | University hospital Košice | Study Chair |
| Tomáš Koller, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| F.D.Roosevelt Teaching Hospital | Banská Bystrica | 97401 | Slovakia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35854275 | Background | Graupera I, Thiele M, Ma AT, Serra-Burriel M, Pich J, Fabrellas N, Caballeria L, de Knegt RJ, Grgurevic I, Reichert M, Roulot D, Schattenberg JM, Pericas JM, Angeli P, Tsochatzis EA, Guha IN, Garcia-Retortillo M, Morillas RM, Hernandez R, Hoyo J, Fuentes M, Madir A, Juanola A, Soria A, Juan M, Carol M, Diaz A, Detlefsen S, Toran P, Pera G, Fournier C, Llorca A, Newsome PN, Manns M, de Koning HJ, Serra-Burriel F, Cucchietti F, Arslanow A, Korenjak M, van Kleef L, Falco JL, Kamath PS, Karlsen TH, Castera L, Lammert F, Krag A, Gines P; LiverScreen Consortium investigators. LiverScreen project: study protocol for screening for liver fibrosis in the general population in European countries. BMC Public Health. 2022 Jul 19;22(1):1385. doi: 10.1186/s12889-022-13724-6. |
Not provided
Not provided
The whole dataset except will be shared with prof. Pere Ginés and the LiverScreen investigators
Data will be available as of December, 2023 - fo one year
Consent of the SIRIUS principal investigator and chairs
Not provided
Not provided
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Stool sample for microbiome analysis by 16S RNA
|
| August, 2022 - September, 2023 |
| Body mass index | As calculated from height and weight (together with waist-to-hip ratio) | August, 2022 - September, 2023 |
| University Hospital Bratislava |
| Study Chair |
| University Hospital Bratislava | Bratislava | 82101 | Slovakia |
|
| Pasteur University Hospital | Košice | 04018 | Slovakia |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D005234 | Fatty Liver |