Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease

Study Overview
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Brief Summary
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Chronic alcoholic and metabolic liver diseases are the two main liver diseases in France. The long-term prognosis of these two diseases are not well known because main studies are retrospective and with only alcoholic patients. The knowledge of the natural history of these diseases should improve the management of patients with such diseases. The aim of this prospective cohort is to describe the natural history of patients with chronic liver disease due to alcohol or metabolic disease and to identify factors associated with complications of these liver diseases (cirrhosis, hepatocellular carcinoma, ascites. ..).

Detailed Description
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In 2010, the two most frequent chronic liver diseases are alcoholic and metabolic disease. The natural history of these two diseases is not well known. Indeed, most of the studies were retrospective and evaluated alcoholic disease or metabolic disease but never both diseases. However, these two diseases have the same histological lesions and can be associated. The knowledge of the natural history of these diseases could improve the management of patients in order to decrease complications and improve survival. The aim of this prospective study is to describe the natural history of chronic liver disease due to alcohol and/or metabolic syndrome and to identify factors associated with complications (ascites, encephalopathy, death, complications of obesity, diabetes or chronic alcohol abuse). All patients will be followed every 6 months for 3 years with clinical, biological and morphological parameters.

Official Title
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Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease

Conditions
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Liver Diseases, Alcoholic, Metabolic Diseases

Intervention / Treatment
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* Other: Intervention according to the standard of care.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years chronic liver disease (liver biopsy with bridging fibrosis or cirrhosis) or non-invasive markers of fibrosis (fibrotest > 0.58, FibroScan > 7.9 kPa) no decompensated cirrhosis chronic alcohol use and/or metabolic syndrome (at least 3 criteria of metabolic syndrome) Written informed consent Patient covered by the French health insurance system Exclusion Criteria: short term life threatening disease Other cirrhosis causes Impossibility of regular follow-up Under guardianship major Patient Presence of focal hurt suggestive of CHC pregnant women cirrhosis complication Child-pugh score superior or equal to 7

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Patients with chronic alcoholic and/or metabolic liver disease | Other: Intervention according to the standard of care.<br>* Every 6 months, patients will have clinical, biological and morphological evaluation according to the standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | up to 84 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of liver disease | ascites, encephalopathy, liver cancer, bleeding from oesophageal varices | up to 84 months | 
| Complications of obesity | cardiovascular diseases, pulmonary diseases, etc. | up to 84 months | 
| Complications of diabetes | renal failure,etc. | up to 84 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Diseases, Alcoholic, Metabolic Diseases, cohort, liver disease