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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01237574
Acronym
CALMET
Enrollment
527
Registered
2010-11-09
Start date
2010-11-23
Completion date
2020-12-12
Last updated
2021-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Diseases, Alcoholic, Metabolic Diseases

Keywords

Liver Diseases, Alcoholic, Metabolic Diseases, cohort, 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 description

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.

Interventions

OTHERIntervention according to the standard of care.

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

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Deathup to 84 months

Secondary

MeasureTime frameDescription
Complications of liver diseaseup to 84 monthsascites, encephalopathy, liver cancer, bleeding from oesophageal varices
Complications of obesityup to 84 monthscardiovascular diseases, pulmonary diseases, etc.
Complications of diabetesup to 84 monthsrenal failure,etc.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026