Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
Not Applicable
Recruiting
- Conditions
- Liver DiseasesAcute on Chronic Hepatic Failure
- Interventions
- Other: collection of liver biopsies collection of blood samples
- Registration Number
- NCT03773887
- Lead Sponsor
- University Hospital, Lille
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alcoholic cirrhosis collection of liver biopsies collection of blood samples collection of liver biopsies collection of blood samples in patients with alcoholic cirrhosis (group B1) acute alcoholic hepatitis collection of liver biopsies collection of blood samples collection of liver biopsies collection of blood samples in patients with acute alcoholic hepatitis (group A) Without chronic liver disease collection of liver biopsies collection of blood samples collection of liver biopsies collection of blood samples in patients without chronic liver disease (group B2)
- Primary Outcome Measures
Name Time Method the expression of proinflammatory cytokines Baseline Proinflammatory Cytokines (TNF, IL-1, IL-6, IL-8)
- Secondary Outcome Measures
Name Time Method the expression of genetic variants of pro-inflammatory cytokines Baseline Identification of genetic variants of pro-inflammatory cytokines that contribute to mortality of Alcoholic Liver Disease
Cell lysis (AST, ALT, CK18 cleaved) Baseline Regeneration markers (Ki-67, Fn14, CK7) Baseline
Trial Locations
- Locations (1)
Hôpital Claude Huriez, CHRU
🇫🇷Lille, France