Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Hôpital Claude Huriez, CHRU
RECRUITING
Lille
Contact Information
Primary
Philippe Mathurin, MD,PhD
philippe.mathurin@chru-lille.fr
03 20 44 55 97
Time Frame
Start Date: 2015-09
Estimated Completion Date: 2027-09
Participants
Target number of participants: 450
Treatments
Other: acute alcoholic hepatitis
collection of liver biopsies collection of blood samples in patients with acute alcoholic hepatitis (group A)
Other: Alcoholic cirrhosis
collection of liver biopsies collection of blood samples in patients with alcoholic cirrhosis (group B1)
Other: Without chronic liver disease
collection of liver biopsies collection of blood samples in patients without chronic liver disease (group B2)
Sponsors
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov