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

Metabolic Diseases Clinical Trial

— CALMET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237574
• Other study ID #: CHUBX 2010/38
• Status: Completed
• Start date: November 23, 2010
• Est. completion date: December 12, 2020

Study information

• Verified date: March 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. ..).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 527
• Est. completion date: December 12, 2020
• Est. primary completion date: December 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases
• Liver Diseases, Alcoholic
• Metabolic Diseases

Intervention

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

Locations

Country	Name	City	State
France	CHU d'Angers	Angers
France	CHU de Besançon - Hôpital Jean Minjoz	Besançon
France	CH Pierre Oudot	Bourgoin
France	CHU de Brest - Hôpital La Cavale Blanche	Brest
France	CHU de Caen	Caen
France	CH de Chateauroux	Chateauroux
France	CHU Clermont-Ferrand - Hôpital Estaing	Clermont-Ferrand
France	CH Laennec	Creil
France	CHU de Grenoble - Hôpital Albert Michallon	Grenoble
France	CH Le Mans	Le Mans
France	GH-ICL - Hôpital Saint Philibert	Lille
France	CH de Limoges - Hôpital Dupuytren	Limoges
France	HCL - Hôpital Hôtel Dieu	Lyon
France	APHM - Hôpital La Conception	Marseille
France	Hôpital Saint-Joseph	Marseille
France	CH de Montauban	Montauban
France	CHU de Nancy - Hôpital de Brabois	Nancy
France	CHU de Nice - Hôpital Archet 2	Nice
France	Hôpital Carémeau	Nimes
France	CHR Orléans - Hôpital La Source	Orléans
France	APHP - Hôpital Bicêtre	Paris
France	APHP - Hôpital Jean Verdier	Paris
France	APHP - Hôpital Paul Brousse	Paris
France	APHP - Hôpital Pitié Salpetrière	Paris
France	APHP - Hôpital Saint-Antoine	Paris
France	APHP - Hôpital Tenon	Paris
France	APHP Hôpital Cochin	Paris
France	APHP- CHU Henri Mondor	Paris
France	CH de Perpignan - Hôpital Saint-Jean	Perpignan
France	CHU de Bordeaux - Hôpital du Haut-Lévêque	Pessac
France	CHRU de Poitiers	Poitiers
France	CHU de Reims - Hôpital Robert Debré	Reims
France	CHU de Rouen	Rouen
France	CHRU de Strasbourg - Nouvel Hôpital Civil	Strasbourg
France	CHU de Toulouse - Hôpital Purpan	Toulouse
France	CHRU de Tours - Hôpital Trousseau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death		up to 84 months
Secondary	Complications of liver disease	ascites, encephalopathy, liver cancer, bleeding from oesophageal varices	up to 84 months
Secondary	Complications of obesity	cardiovascular diseases, pulmonary diseases, etc.	up to 84 months
Secondary	Complications of diabetes	renal failure,etc.	up to 84 months