Clinical trial NCT01237574: Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease
Official title: Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases, Alcoholic
Metabolic Diseases
Keywords: Liver Diseases
Alcoholic
Metabolic Diseases
cohort
liver disease
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 years old patient with 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Death
timeFrame: up to 84 months
Secondary outcomes:
measure: Complications of liver disease
timeFrame: up to 84 months
measure: Complications of obesity
timeFrame: up to 84 months
measure: Complications of diabetes
timeFrame: up to 84 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Besançon
country: France
facility: CHU de Besançon - Hôpital Jean Minjoz
city: Bourgoin
country: France
facility: CH Pierre Oudot
city: Brest
country: France
facility: CHU de Brest - Hôpital La Cavale Blanche
city: Caen
country: France
facility: CHU de Caen
city: Chateauroux
country: France
facility: CH de Chateauroux
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand - Hôpital Estaing
city: Creil
country: France
facility: CH Laennec
city: Grenoble
country: France
facility: CHU de Grenoble - Hôpital Albert Michallon
city: Le Mans
country: France
facility: CH Le Mans
city: Lille
country: France
facility: GH-ICL - Hôpital Saint Philibert
city: Limoges
country: France
facility: CH de Limoges - Hôpital Dupuytren
city: Lyon
country: France
facility: HCL - Hôpital Hôtel Dieu
city: Marseille
country: France
facility: APHM - Hôpital La Conception
city: Marseille
country: France
facility: Hôpital Saint-Joseph
city: Montauban
country: France
facility: CH de Montauban
city: Nancy
country: France
facility: CHU de Nancy - Hôpital de Brabois
city: Nice
country: France
facility: CHU de Nice - Hôpital Archet 2
city: Nimes
country: France
facility: Hôpital Carémeau
city: Orléans
country: France
facility: CHR Orléans - Hôpital La Source
city: Paris
country: France
facility: APHP - Hôpital Bicêtre
city: Paris
country: France
facility: APHP - Hôpital Jean Verdier
city: Paris
country: France
facility: APHP - Hôpital Paul Brousse
city: Paris
country: France
facility: APHP - Hôpital Pitié Salpetrière
city: Paris
country: France
facility: APHP - Hôpital Saint-Antoine
city: Paris
country: France
facility: APHP - Hôpital Tenon
city: Paris
country: France
facility: APHP Hôpital Cochin
city: Paris
country: France
facility: APHP- CHU Henri Mondor
city: Perpignan
country: France
facility: CH de Perpignan - Hôpital Saint-Jean
city: Pessac
country: France
facility: CHU de Bordeaux - Hôpital du Haut-Lévêque
city: Poitiers
country: France
facility: CHRU de Poitiers
city: Reims
country: France
facility: CHU de Reims - Hôpital Robert Debré
city: Rouen
country: France
facility: CHU de Rouen
city: Strasbourg
country: France
facility: CHRU de Strasbourg - Nouvel Hôpital Civil
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Purpan
city: Tours
country: France
facility: CHRU de Tours - Hôpital Trousseau
Study officials:
References: