Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- the expression of proinflammatory cytokines
研究概览
简要总结
The main objective of this study is the comparison of the profile of the pro-inflammatory cytokines at the patients suffering from an alcoholic hepatitis to that of two groups witnesses: patients suffering from an alcoholic cirrhosis and unhurt patients of chronic liver disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •group A: patients with acute alcoholic hepatitis
- •Active alcohol abuse defined by DSM IV and excessive alcohol consumption prior to admission (> 60 g per day for men and> 40 g per day for women)
- •Moderate elevation of transaminases (less than 500 U / L) with a typical ASAT / ALAT ratio of 2: 1
- •Bilirubin> 50 mg / l
- •Absence of autoimmune liver disease (ANA <1/80, AML <1/80, LKM1 neg, AAM neg)
- •Absence of hepatitis B and C and HIV infection (negative anti-HIV antibodies, negative HBsAg, negative HCV PCR)
- •Patients with other acute complications than alcoholic hepatitis may be included (eg, digestive hemorrhage, acute renal failure, infection, etc.)
- •Because there is no validated noninvasive tool for the diagnosis of alcoholic hepatitis, histological confirmation is required in all patients (preferably by transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the following histological characteristics: Hepatocellular lesions (ballooning, Mallory body)/ Inflammatory infiltrate with polymorphonuclear neutrophils
- •group B1: patients with alcoholic cirrhosis
- •Decompensated or non-decompensated alcoholic cirrhosis, defined according to the HAS guidelines, ie by a liver biopsy or a cluster of clinico-biological arguments (www.has-sante.fr)
- •group B2: patients free from chronic liver disease
- •Justification of blood and liver sampling for the management of a pathology other than chronic liver disease (eg liver metastasis of digestive cancer occurring on healthy liver)
排除标准
- •For groups A and B1:
- •Patients with hepatocellular carcinoma of progressive non-hepatic cancer
- •Presence of HBsAg
- •Presence of anti-HCV antibodies by positive PCR
- •Presence of antibodies to HIV 1 +2
- •Pregnancy
- •for group B2:
- •Alcoholic liver disease
- •Presence of HBsAg
- •Presence of anti-HCV antibodies by positive PCR
- •Presence of antibodies to HIV 1 +2
- •Pregnancy
研究组 & 干预措施
acute alcoholic hepatitis
collection of liver biopsies collection of blood samples in patients with acute alcoholic hepatitis (group A)
干预措施: collection of liver biopsies collection of blood samples (Other)
Alcoholic cirrhosis
collection of liver biopsies collection of blood samples in patients with alcoholic cirrhosis (group B1)
干预措施: collection of liver biopsies collection of blood samples (Other)
Without chronic liver disease
collection of liver biopsies collection of blood samples in patients without chronic liver disease (group B2)
干预措施: collection of liver biopsies collection of blood samples (Other)
结局指标
主要结局
the expression of proinflammatory cytokines
时间窗: Baseline
Proinflammatory Cytokines (TNF, IL-1, IL-6, IL-8)
次要结局
- the expression of genetic variants of pro-inflammatory cytokines(Baseline)
- Cell lysis (AST, ALT, CK18 cleaved)(Baseline)
- Regeneration markers (Ki-67, Fn14, CK7)(Baseline)