Screening of Liver Fibrosis in Adults Without Known Liver Disease or With Previously Diagnosed Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Liver fibrosis
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult, written informed consent
排除标准
- •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
结局指标
主要结局
Liver fibrosis
时间窗: August, 2022 - to September 2023
The amount of fibrous tissue in the liver according to non-invasive tests
次要结局
- Non-alcoholic fatty liver disease(August, 2022 - September, 2023)
- Alcohol associated liver disease(August, 2022 - September, 2023)
- Body mass index(August, 2022 - September, 2023)
研究者
Ľubomír Skladaný MD, PhD
MD, PhD
F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica