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OpenTrials
Completed

NCT Number: NCT01237574

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

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. ..).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention according to the standard of care.

Other

Every 6 months, patients will have clinical, biological and morphological evaluation according to the standard of care.

Primary outcomes

  1. Death

    Time frame: up to 84 months

Secondary outcomes

  1. Complications of liver disease

    Time frame: up to 84 months

    ascites, encephalopathy, liver cancer, bleeding from oesophageal varices

  2. Complications of obesity

    Time frame: up to 84 months

    cardiovascular diseases, pulmonary diseases, etc.

  3. Complications of diabetes

    Time frame: up to 84 months

    renal failure,etc.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: CALMET

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Nov 9, 2010
Registry last updated
Mar 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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