Recruiting
Not applicable
Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
Condition(s) studied
Liver DiseasesAcute on Chronic Hepatic Failure
Investigational drug(s) / intervention(s)
collection of liver biopsies collection of blood samples
collection of liver biopsies collection of blood samples: blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies
Study 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
Eligibility
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
Primary outcome measure(s)
- the expression of proinflammatory cytokines — Baseline
Proinflammatory Cytokines (TNF, IL-1, IL-6, IL-8)
Trial sites (1)
| Facility | City | Region | Status |
| Hôpital Claude Huriez, CHRU |
Lille |
France |
Recruiting |
More University Hospital, Lille trials in France
Other trials for the same condition