About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
History established / suggestive of HAA (Clinical, biological and / or histological criteria) in particular absence of jaundice episode
Trial population
Patients admitted to jaundice will receive a liver biopsy in accordance with the usual management for diagnosis of alcoholic hepatitis, according to the recommendations of the European Association of Liver Diseases (EASL).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Prevalence of alcoholic hepatitis in heavy drinkers with jaundice
Assess the prevalence of biopsy-proven alcoholic hepatitis in a cohort of heavy drinkers admitted with recent jaundice
Secondary outcomes
Survival
Survival rate at 12 months
Change in serum total bilirubin
Total bilirubin is a liver parameter, used for the biological liver test evaluation, measured in mg/dl in the serum
Change in serum creatinine
Creatinine is a marker of kidney function, assessed in the blood and measured in milligrams per deciliter
Change in MELD (Model for End-stage Liver Disease)score
The MELD score is a validated tool based on INR, creatinine and bilirubin measured in the blood with the following formula:(9.57 × log creatinine in milligrams per deciliter) + (3.78 × log bilirubin in milligrams per deciliter) + (11.20 × log international normalized ratio) + 6.43. The MELD score is used in liver disorders to assess the degree of liver failure. It has no unit.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.