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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

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

Brief Summary:

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 Summary: 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.
Sponsor: University Hospital, Bordeaux

Current Primary Outcome: Death [ Time Frame: up to 36 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Complications of liver disease [ Time Frame: up to 36 months ]
  ascites, encephalopathy, liver cancer, bleeding from oesophageal varices
• Complications of obesity [ Time Frame: up to 36 months ]
  cardiovascular diseases, pulmonary diseases, etc.
• Complications of diabetes [ Time Frame: up to 36 months ]
  renal failure,etc.

Original Secondary Outcome: Same as current

Information By: University Hospital, Bordeaux

Dates:
Date Received: October 25, 2010
Date Started: December 2010
Date Completion: June 2015
Last Updated: March 4, 2015
Last Verified: March 2015