Understanding Alcohol-related Liver Disease in Europe

Evaluation of the Natural History of Alcoholic Liver Disease According to Baseline Severity

This study looks at how alcohol-related liver disease develops in heavy drinkers to see if non-invasive tests can help identify those at risk of serious liver damage.

Quick facts

• Study type: Observational
• Enrollment: 7500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University Hospital, Lille (Academic / other)
• Locations: 1 site (Lille)
• Trial ID: NCT04400604 on ClinicalTrials.gov

What this trial studies

This observational study focuses on the progression of alcohol-related liver disease, including conditions such as fatty liver, fibrosis, and alcoholic hepatitis. It aims to utilize non-invasive diagnostic methods to track disease progression and identify patients at risk of developing cirrhosis. By studying asymptomatic heavy drinkers, the research seeks to establish risk cut-offs for cirrhosis development and improve screening strategies for patients with significant liver damage. The study will involve assessments like abdominal ultrasound and liver stiffness measurements to gather comprehensive data.

Who should consider this trial

Good fit: Ideal candidates are individuals with a history of excessive alcohol consumption, defined as more than 210 grams per week for men and more than 140 grams per week for women.

Not a fit: Patients who do not consume alcohol excessively or those with already diagnosed advanced liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better screening and management strategies for patients at risk of cirrhosis due to alcohol-related liver disease.

How similar studies have performed: Other studies have shown promise in using non-invasive methods for assessing liver disease progression, indicating that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Active alcohol excessive consumption defined as \> 210 g per week for men and\> 140 g per week for women during the previous year.
* Patients with high risk of alcoholic-related liver disease can be included only if the following assessment were available: Abdominal Ultrasound / Ultrasound elastography pulse (FibroScan®) / FibroTest®, AshTest® and LCR1-LCR2® (cost will be supported by Biopredictive) / Non-patented methods: Forns Index; Fib-4, Hepascore®/ Absolute values should be provided for all these methods.

For patient in whom liver stiffness measurements were uninterpretable (unavailable results) only those with FibroTest® and LCR1 and LCR2 measurements can be included.

Results of FibroScan® were considered unavailable based on following criteria: When no value was obtained after at least 10 shots (valid shot=0) OR If SR (Success Rate), the ratio of valid shots to the total number of shots at least 60% OR IQR (InterQuartil Range reflecting variability of measurements) less than 30% of the median LSM (Liver Stiffness Measure) value (IQR≤LSM≤30%).

* Patients must provide written informed consent and agree to have blood stored for the study and tissue stored for those in whom physicians performed liver biopsy according their clinical practice.
* Patients should agree to participate for at least 5-year follow-up.
* Patients with social insurance

Exclusion Criteria:

For all study groups, the following exclusion criteria will be applied:

* Evidence of other forms of known chronic liver disease including:Positive test result at baseline for hepatitis B surface antigen or positive serology of hepatitis C virus infection (regardless PCR results)/ Autoimmune liver disease / Known or suspected HCC
* Any previous episode of decompensated liver disease, including ascites, hepatic encephalopathy, or variceal bleeding before current hospitalization and/or inclusion in the study
* Known positivity for human immunodeficiency virus infection.
* Terminal extrahepatic illness defined as: All conditions evolved into a clinical stage to limit the patient's functional status (e.g.: heart failure, renal failure, neurological or respiratory diseases, or any other disabling diseases etc. …).
* Other medical conditions that may diminish life expectancy to \<2 years.
* Known extra-hepatic cancers with the exception of basal cell skin cancer.
* Any other condition that, in the opinion of the Investigator, would impede completion of the study (eg: Homeless, non-compliant patients…).
* Mental instability or incompetence, such that the validity of informed consent is uncertain.
* Lack of informed consent or refusal to participate for follow up evaluation.
* A condition in which repeated blood draws pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.
* Pregnant or lactating women

Where this trial is running

Lille

• Hop Claude Huriez Chu Lille — Lille, France (Recruiting)

Study contacts

• Principal investigator: Philippe Mathurin, MD,PhD — University Hospital, Lille
• Study coordinator: Philippe Mathurin, MD,PhD

Conditions Alcoholic Liver Disease