Non-invasive Screening for Chronic Liver Diseases in the General Population. A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Evaluation of the liver fibrosis screening acceptability (FIB-4)
研究概览
简要总结
Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care.
详细描述
The prevalence of chronic liver diseases continues to increase on the one hand by the increase in non-alcoholic fatty liver disease (NAFLD) which affects 25% of the general population as well as the increased incidence of hepatocellular carcinoma in recent years. Screening for liver fibrosis in the general population represents a major public health issue.
The FIB-4 score is obtained by a blood test. This score combines age, measurement of ALT/ASAT (alanine aminotransferase / aspartate-aminotransferase) and platelet count. This score is sensitive for detecting advanced fibrosis liver and allows 71% of patients to avoid a liver biopsy.
Transient elastometry (Fibroscan®) is another very effective non-invasive assessment in the diagnosis of chronic liver diseases and hepatic fibrosis. It has already been demonstrated by several studies that combining several non-invasive fibrosis tests allows to improve the precision of the result.
The investigators hypothesize that offering an additional assessment by Fibroscan for patients screened by a blood test (FIB-4 Score) as possibly having advanced liver fibrosis (Score >1.3) will raise awareness among professional practitioners and the general population with chronic liver diseases and refine screening for chronic liver diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years
- •Without known liver pathologies
- •Having at least one risk factor for chronic liver disease: risky consumption of alcoholic beverages according to the AUDIT questionnaire, the presence of metabolic syndrome, diabetes or a risk factor for viral hepatitis B, D or C.
排除标准
- •Fibroscan already performed in the last 12 months
- •Failure to collect express oral consent
- •Patient not affiliated with or not benefiting from a national health insurance scheme
- •Patient protected by law
- •Patient under guardianship or curatorship
- •Patient deprived of liberty
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Population with a chronic liver disease risk factor
Patient aged ≥ 40 years, with no known liver disease, consulting a general practitioner and having at least one risk factor for chronic liver disease: risky consumption of alcoholic beverages according to the AUDIT questionnaire, the presence of a metabolic syndrome, diabetes or a risk factor for viral hepatitis B/D or C.
干预措施: Blood sample then fibroscan (Diagnostic Test)
结局指标
主要结局
Evaluation of the liver fibrosis screening acceptability (FIB-4)
时间窗: During the inclusion assessment at day 1 (Visit 0)
percentage of patients who agreed to a FIB-4 blood test among all included patients offered screening.
Evaluation of the liver fibrosis screening acceptability (FIB-4 and Fibroscan)
时间窗: During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1)
percentage of patients who agreed to a FIB-4 blood test FIB-4 followed by Fibroscan (if FIB-4 score\>1.3) among all included patients offered screening.
次要结局
- Prevalence of advanced liver fibrosis by elastometry pulse (Fibroscan®) with a FIB-4 score>1.3(During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1))
- Prevalence of excessive consumption of alcohol(During the inclusion assessment at day 1 (Visit 0))
- Prevalence of a history or drug use(During the inclusion assessment at day 1 (Visit 0))
- The correlation between advanced liver fibrosis and risk factors for liver disease (presence of metabolic syndromes, viral hepatitis, alcool use disorders)(During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1))
- prevalence of viral hepatitis(During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1))
- Description of socio-demographic characteristics of participants(During the inclusion assessment at day 1 (Visit 0))