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

Completed

• Conditions: Metabolic Diseases; Liver Diseases, Alcoholic
• Interventions: Other: Intervention according to the standard of care.

• Registration Number: NCT01237574
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Study Start: 2010-11-23
• Primary Completion: 2020-12-12
• Study Completion: 2020-12-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-25
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 527

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Intervention according to the standard of care.	Patients with chronic alcoholic and/or metabolic liver disease

Primary Outcome Measures

Name	Time	Method
Death	up to 84 months

Secondary Outcome Measures

Name	Time	Method
Complications of obesity	up to 84 months	cardiovascular diseases, pulmonary diseases, etc.
Complications of diabetes	up to 84 months	renal failure,etc.
Complications of liver disease	up to 84 months	ascites, encephalopathy, liver cancer, bleeding from oesophageal varices

Trial Locations

Locations (36)

CHU de Grenoble - Hôpital Albert Michallon; 🇫🇷 Grenoble, France

CHU Clermont-Ferrand - Hôpital Estaing; 🇫🇷 Clermont-Ferrand, France

CHU d'Angers; 🇫🇷 Angers, France

CH Laennec; 🇫🇷 Creil, France

Hôpital Carémeau; 🇫🇷 Nimes, France

CHR Orléans - Hôpital La Source; 🇫🇷 Orléans, France

APHP - Hôpital Bicêtre; 🇫🇷 Paris, France

CHU de Besançon - Hôpital Jean Minjoz; 🇫🇷 Besançon, France

CH Pierre Oudot; 🇫🇷 Bourgoin, France

APHP - Hôpital Jean Verdier; 🇫🇷 Paris, France

APHP Hôpital Cochin; 🇫🇷 Paris, France

CHU de Brest - Hôpital La Cavale Blanche; 🇫🇷 Brest, France

CHU de Caen; 🇫🇷 Caen, France

CH de Chateauroux; 🇫🇷 Chateauroux, France

CHRU de Strasbourg - Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France

CHU de Toulouse - Hôpital Purpan; 🇫🇷 Toulouse, France

APHP - Hôpital Paul Brousse; 🇫🇷 Paris, 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

CHU de Nice - Hôpital Archet 2; 🇫🇷 Nice, France

Hôpital Saint-Joseph; 🇫🇷 Marseille, France

CH de Montauban; 🇫🇷 Montauban, France

CHU de Nancy - Hôpital de Brabois; 🇫🇷 Nancy, France

CHRU de Poitiers; 🇫🇷 Poitiers, France

APHP - Hôpital Pitié Salpetrière; 🇫🇷 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

APHP - Hôpital Tenon; 🇫🇷 Paris, France

APHP - Hôpital Saint-Antoine; 🇫🇷 Paris, France

CHU de Reims - Hôpital Robert Debré; 🇫🇷 Reims, France

CHU de Rouen; 🇫🇷 Rouen, France

CHRU de Tours - Hôpital Trousseau; 🇫🇷 Tours, France