Out-of-hospital Screening of Patients With Significant Hepatic Fibrosis or Cirrhosis and Viral Hepatitis B and C
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Prevalence of significant hepatic fibrosis in the general population of Seine Saint Denis
研究概览
简要总结
Regardless of its etiology (chronic hepatitis B or C, alcohol consumption, metabolic steatohepatitis, hemochromatosis, autoimmune liver disease), cirrhosis is a real public health issue. Cirrhosis is a chronic disease and can get complicated by liver cancer, digestive hemorrhage, or liver failure, which are responsible for morbidity and mortality.
In France, cirrhosis prevalence is estimated at 700,000 patients and induce 16,000 deaths per year (10,000 liver cancer and 6,000 liver decompensation). In Ile-de-France area, cirrhosis prevalence is estimated at 130,000 cases, a lot of them are in Seine Saint Denis department due to precariousness.
Hepatitis C virus can now be cured and hepatitis B treatment can suspend hepatitis B replication. All these treatments reduce liver complications but even after virological cure, cirrhosis requires dedicated long term management as well as alcoholic liver disease and metabolic steatohepatitis at cirrhosis stage.
Periodic screening for complications and specific measures were defined by french HAS in 2007 (medication intake, dietary management and specific vaccinations), especially the performance of a semi-annual liver ultrasound for hepatocellular carcinoma (HCC) screening.
Then, it seems essential to screen for patients with viral hepatitis and extensive fibrosis or cirrhosis in our department to achieve active and individualized management of this chronic liver disease, to reduce long term morbidity and mortality.
The main aim of the study is to evaluate the prevalence of advanced liver fibrosis and viral infections B and C in the general population of Seine Saint Denis, using a dual screening method of TROD (rapid diagnostic orientation test) and FibroScan®, combined with a care pathway
详细描述
Targeted population
The targeted population will be users of one municipal health center visiting the municipal health center on a given day We will propose a screening for liver fibrosis using Fibroscan mini® and will propose rapid diagnostic orientation tests (TROD) for HCV and HBV viral infection, by a traveling physician Expérimental scheme
Proposal by the caregiver to each patient at the center :
- Fibroscan®
- TROD VHC / VHB IF Fibroscan ≥ 9.6 KPa or positive HCV TROD or HBsAg positive THEN Suggested appointment Avicenne hospital hepatology consultation or Jean Verdier hepatology consultation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years
- •Collection of signed consent
- •Patients affiliated to a Social Security System
排除标准
- •Pregnancy or breastfeeding
- •Subjects under AME
- •Persons under court protection
- •Guardianship or curatorship,
- •Safeguard of justice
- •Persons under psychiatric care without their consent
- •Persons admitted to a health or social institution for purposes other than research,
- •Patients of full age under legal protection (guardianship or curatorship)
- •Persons unable to express their consent.
研究组 & 干预措施
Patients of a municipal health center who visit the municipal health center on a given day.
干预措施: TROD (rapid diagnostic orientation test) and FibroScan® (Diagnostic Test)
结局指标
主要结局
Prevalence of significant hepatic fibrosis in the general population of Seine Saint Denis
时间窗: Two year of inclusion period
次要结局
- Chronic hepatitis B prevalence(Two year of inclusion period)
- Chronic hepatitis C prevalence(Two year of inclusion period)
- Proportion of eligible patients for management of viral hepatitis B and C(Two year of inclusion period)
- Prevalence of other causes of chronic liver disease (alcohol and NASH)(Two year of inclusion period)
- Proportion of patients managed in hepatology department after screening for significant fibrosis(Two year of inclusion period)
- Prevalence of confirmed significant liver fibrosis in patients referred to hepatology consultation(Two years of inclusion period)
- Proportion of patients with ultrasound signs of cirrhosis and hepatocellular carcinoma among patients referred to hepatology consultation (managed according to current hepatology guidelines).(Two years of inclusion period)