RecruitingNCT04106518

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


Sponsor

University Hospital, Lille

Enrollment

447 participants

Start Date

Oct 23, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria19

  • 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 Criteria9

  • 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

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Locations(9)

Chr Angers

Angers, France

Chru Besancon

Besançon, France

Hôpital Jean Verdier, AH-HP

Bondy, France

Centre Hospitalier Universitaire

Caen, France

Hopital Nord - Chu38 - La Tronche

La Tronche, France

Hôpital Claude Huriez, CHU

Lille, France

Association Hopital Saint Joseph - Marseille

Marseille, France

Chu Montpellier

Montpellier, France

Hu Est Parisien Site St Antoine Aphp - Paris 12

Paris, France

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NCT04106518


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