Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease (COMADHAA)

University Hospital, Lille

Status

Enrolling

Conditions

Alcoholic Cirrhosis

Severe Alcoholic Hepatitis

Alcoholic Liver Disease

Study type

Observational

Funder types

Other

Identifiers

NCT04106518

2018-A02286-49 (Other Identifier)

2017_51

Details and patient eligibility

About

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.

Enrollment

447 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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