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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

447 Participants
are grouped into 3 trial groups
Group A: cirrhosis
Group B: severe alcoholic hepatitis
Group C: non-severe alcoholic hepatitis

Trial outcomes

Primary outcomes

1

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

Time frame
At baseline (time of liver biopsy)

Secondary outcomes

1

Survival

Survival rate at 12 months

Time frame
at 12 months
2

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

Time frame
Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
3

Change in serum creatinine

Creatinine is a marker of kidney function, assessed in the blood and measured in milligrams per deciliter

Time frame
Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months
4

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.

Time frame
Baseline, at 7 days, at 30 days, at 3 months at 6 months and at 12 months

Other outcomes

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