Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 447
- 试验地点
- 9
- 主要终点
- Prevalence of alcoholic hepatitis in heavy drinkers with jaundice
研究概览
简要总结
Alcoholic hepatitis carries a risk of high mortality at short term, especially in its severe form. Its diagnosis is confirmed by liver biopsy. The prevalence of alcoholic hepatitis, severe or not severe, is poorly known and prospective data are needed. The present observational study aims to define the prevalence of alcoholic hepatitis among patients admitted for jaundice and determine their outcome according to the severity. Survival and markers of liver dysfunction will be assessed. A biobank including genetic samples will be created to identify the disease profile in terms of inflammation and regeneration. The performance of non-invasive criteria for diagnosis will also be studied.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •For SAH group:
- •Alcohol consumption :
- •On average> 40 g / day for women and 50 g / day for men
- •Duration:> 5 years
- •Recent jaundice episode (less than 3 months)
- •Bilirubin> 50 mg / l (85μmol / l)
- •For NSAH group:
- •- Alcohol consumption :
- •On average> 40 g / day for women and 50 g / day for men
- •Duration:> 5 years
- •For cirrhosis (control) group:
- •Alcohol consumption :
- •On average> 40 g / day for women and 50 g / day for men
- •Duration:> 5 years
- •Unambiguous presence of cirrhosis criteria, including:
- •clinical signs (ascites, stellar angiomas ...) and / or
- •radiological signs (scanner or MRI: signs of hepatic dysmorphism and / or portal hypertension) and / or
- •biological signs (increased INR, thrombocytopenia) and / or
- •endoscopic signs (oesophageal / gastric varices)
排除标准
- •For NAH and NSAH groups:
- •Presence of another hepatic pathology: evidenced by blood biology, imaging or histology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)
- •Presence of hepatocellular carcinoma
- •HIV infection
- •For cirrhosis (control) group:
- •History established / suggestive of HAA (Clinical, biological and / or histological criteria) in particular absence of jaundice episode
- •Presence of another hepatic pathology: evidenced by blood biology, imaging or histology (viral or autoimmune hepatitis, hemochromatosis, Wilson's disease)
- •Presence of hepatocellular carcinoma
- •HIV infection
研究组 & 干预措施
cirrhosis
Patients with alcoholic liver disease without alcoholic hepatitis
severe alcoholic hepatitis
Patients with severe alcoholic hepatitis ( Maddrey score ≥32)
non-severe alcoholic hepatitis
Patients with non-severe alcoholic hepatitis (Maddrey score <32)
结局指标
主要结局
Prevalence of alcoholic hepatitis in heavy drinkers with jaundice
时间窗: At baseline (time of liver biopsy)
Assess the prevalence of biopsy-proven alcoholic hepatitis in a cohort of heavy drinkers admitted with recent jaundice
次要结局
- Survival(at 12 months)
- Measurement of diagnostic performance (area under the ROC curve)(At baseline)
- Change in serum total bilirubin(Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months)
- Change in serum creatinine(Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months)
- Change in MELD (Model for End-stage Liver Disease)score(Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months)
- Identification of inflammatory and biochemical profiles of patients with severe, non-severe and cirrhotic alcoholic hepatitis, based on the constitution of a biobank (serum and plasma)(Baseline, at 7 days, at 30 days and at 12 months)
- Identification of the genetic profiles of individuals with severe, non-severe and cirrhotic alcoholic hepatitis( blood sample)(Baseline)