Clinical Trials Logo

Clinical Trial Summary

Alcohol-induced liver injury is made up of fatty liver, fibrosis and alcoholic hepatitis (AH), elementary lesions that may occur separately, simultaneously or sequentially in a same patient. Among these histological features, alcoholic hepatitis, a necro-inflammatory process is associated with the fastest fibrosis progression leading to cirrhosis in 40% of cases and a pivotal lesion driving increased risk of liver decompensation. The non-invasive methods for the diagnosis of fibrosis open new perspectives for a better understanding of the natural history of disease-progression from early injury to the cirrhotic stage, for the identification of subgroup patients at risk of developing cirrhosis at medium term and for proposing a strategy of screening of patients with extensive cirrhosis at risk of liver-threatening events. There is an urgent need to perform studies in asymptomatic heavy drinkers in order to identify cut-offs associated with significant risk of development of cirrhosis at medium term. Such objectives require large-scale screening of heavy drinkers. Each of non-invasive methods have been tested to predict with of extensive fibrosis with a high predictive performance as shown below. A screening policy cannot be accepted without answering the following questions: a) are the requirements of public health screening fulfilled? b) Is the group of patients undergoing screening defined? c) is there a reliable method for of testing? Indeed, the detection of a disease is subject to certain public health requirements and may be proposed to health authorities only if it modifies the management of subjects screened. In the specific case of mass screening of liver fibrosis in heavy drinkers, only the detection of extensive fibrosis could fulfill this criterion because of the potential survival benefit resulting from the screening of hepatocellular carcinoma (HCC) in patients with extensive fibrosis. Indeed, recent studies have found that the probability of receiving curative treatment of HCC was significantly higher in patients who received a six-month surveillance ultrasound. Therefore, the detection of extensive fibrosis seems reasonable in the light of these studies when considering that the yearly risk of development of HCC in the subgroup of heavy drinkers with extensive fibrosis is approximately 3%. Taking into account the above scientific arguments, the most recent EASL clinical practical guidelines on ALD recommend longitudinal studies using non-invasive tools to evaluate screening of extensive fibrosis and disease progression in heavy drinkers.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04400604
Study type Observational
Source University Hospital, Lille
Contact Philippe Mathurin, MD,PhD
Phone 3 20 44 55 97
Email philippe.mathurin@chru-lille.fr
Status Recruiting
Phase
Start date March 3, 2021
Completion date March 2032

See also
  Status Clinical Trial Phase
Completed NCT00708617 - FIBROSCAN Validation and Interest of Fibrotest - FIBROSCAN Association for Fibrosis Diagnosis in Alcoholic Liver Disease N/A
Completed NCT00990639 - Effect of Candesartan in Alcoholic Liver Fibrosis Phase 1/Phase 2
Recruiting NCT04666402 - Integrated Diagnostics for Early Diagnosis of Liver Disease
Recruiting NCT04106518 - Study of Genetic Determinants in Alcoholic Hepatitis and Establishment of a Multicenter Prospective Cohort of Patients With Alcoholic Liver Disease
Recruiting NCT02331745 - RCT Study on Granulocyte Colony-stimulating Factor(G-CSF) Treatment of Hepatic Failure Phase 4
Completed NCT01501162 - Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease Phase 4
Recruiting NCT05895890 - French National MICMAF Cohort
Completed NCT04557774 - Cognitive Function of Alcoholic Compensated Liver Cirrhosis
Recruiting NCT03267069 - Evaluating Alcohol Use in Alcoholic Liver Disease
Recruiting NCT03295812 - Stratification of Chronic Alcoholic Liver Diseases (SCALE Study) N/A
Recruiting NCT05855031 - The Liver Care Trial N/A
Not yet recruiting NCT03503708 - Herbal Supplements for Improvement of Liver Function in Participants With Alcoholic Liver Disease N/A
Completed NCT02796469 - Meta-Analysis of Drug Therapy in Patients With Severe Alcoholic Hepatitis N/A
Completed NCT02140294 - Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease N/A
Recruiting NCT03209791 - Ethanol Induces Skeletal Muscle Autophagy
Recruiting NCT04736966 - Guselkumab (Anti-IL 23 Monoclonal Antibody) for Alcohol Associated Liver Disease Phase 1
Completed NCT03402256 - Text Messaging to Reduce Alcohol Relapse in Liver Transplant Patients N/A
Completed NCT01711125 - Baclofen in the Treatment of Alcohol Dependence With or Without Alcoholic Liver Disease Phase 3
Active, not recruiting NCT03863730 - Profermin®: Prevention of Progression in Alcoholic Liver Disease by Modulating Dysbiotic Microbiota N/A
Not yet recruiting NCT06307964 - Intra-Hepatic Microbiota in Alcoholic Hepatitis