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

NCT ID: NCT01237574

Last Updated: 2021-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

527 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-23

Study Completion Date

2020-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Diseases, Alcoholic Metabolic Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients

Patients with chronic alcoholic and/or metabolic liver disease

Intervention according to the standard of care.

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention according to the standard of care.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU d'Angers

Angers, , France

Site Status

CHU de Besançon - Hôpital Jean Minjoz

Besançon, , France

Site Status

CH Pierre Oudot

Bourgoin, , France

Site Status

CHU de Brest - Hôpital La Cavale Blanche

Brest, , France

Site Status

CHU de Caen

Caen, , France

Site Status

CH de Chateauroux

Châteauroux, , France

Site Status

CHU Clermont-Ferrand - Hôpital Estaing

Clermont-Ferrand, , France

Site Status

CH Laennec

Creil, , France

Site Status

CHU de Grenoble - Hôpital Albert Michallon

Grenoble, , France

Site Status

CH Le Mans

Le Mans, , France

Site Status

GH-ICL - Hôpital Saint Philibert

Lille, , France

Site Status

CH de Limoges - Hôpital Dupuytren

Limoges, , France

Site Status

HCL - Hôpital Hôtel Dieu

Lyon, , France

Site Status

APHM - Hôpital La Conception

Marseille, , France

Site Status

Hôpital Saint-Joseph

Marseille, , France

Site Status

CH de Montauban

Montauban, , France

Site Status

CHU de Nancy - Hôpital de Brabois

Nancy, , France

Site Status

CHU de Nice - Hôpital Archet 2

Nice, , France

Site Status

Hôpital Carémeau

Nîmes, , France

Site Status

CHR Orléans - Hôpital La Source

Orléans, , France

Site Status

APHP - Hôpital Bicêtre

Paris, , France

Site Status

APHP - Hôpital Jean Verdier

Paris, , France

Site Status

APHP - Hôpital Paul Brousse

Paris, , France

Site Status

APHP - Hôpital Pitié Salpetrière

Paris, , France

Site Status

APHP - Hôpital Saint-Antoine

Paris, , France

Site Status

APHP - Hôpital Tenon

Paris, , France

Site Status

APHP Hôpital Cochin

Paris, , France

Site Status

APHP- CHU Henri Mondor

Paris, , France

Site Status

CH de Perpignan - Hôpital Saint-Jean

Perpignan, , France

Site Status

CHU de Bordeaux - Hôpital du Haut-Lévêque

Pessac, , France

Site Status

CHRU de Poitiers

Poitiers, , France

Site Status

CHU de Reims - Hôpital Robert Debré

Reims, , France

Site Status

CHU de Rouen

Rouen, , France

Site Status

CHRU de Strasbourg - Nouvel Hôpital Civil

Strasbourg, , France

Site Status

CHU de Toulouse - Hôpital Purpan

Toulouse, , France

Site Status

CHRU de Tours - Hôpital Trousseau

Tours, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHUBX 2010/38

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The European NAFLD Registry
NCT04442334 RECRUITING