Status:
WITHDRAWN
Early Detection of Alcoholic Liver Disease
Lead Sponsor:
University of Pittsburgh
Conditions:
Alcoholic Liver Disease
Alcoholic Fibrosis of Liver
Eligibility:
All Genders
21+ years
Brief Summary
This is an observational study to identify the prevalence of advanced liver fibrosis among patients with excessive alcohol intake using a non-invasive method (FibroScan®) and to characterize the main ...
Detailed Description
Background: The Global Status Report on Alcohol and Health 2014 from the World Health Organization indicates that alcohol abuse accounts for 50% of cirrhosis worldwide. Therefore, alcoholic liver dis...
Eligibility Criteria
Inclusion
- Patients diagnosed with an alcohol use disorder (AUD) identification test (AUDIT) with a total score of 8 or more or patients with a score lower than 8 in the AUDIT test but for whom there is a high suspicion of current or recent (within one year) AUD based on medical history or self-reported history of excessive alcohol use, stigmata of alcohol use on physical exam, liver chemistry abnormalities, and/or alcohol-induced organ involvement other than decompensated liver disease.
- Patients who admit having a persistent alcohol intake of more than 40 g/daily for women and 60 g/daily for men.
- Patients with abnormal AST, ALT, GGT and/or bilirubin.
- 21 years of age or older.
- Signed informed consent.
Exclusion
- Patients with a history of liver disease or decompensated advanced liver disease (i.e: jaundice episodes, ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome) or known hepatocellular carcinoma.
- Patients with severe extrahepatic disease or terminal illness.
- Patients who are pregnant or breast-feeding. However, pre-menopausal women capable of bearing children will be allowed to participate in the study provided they have a reliable method of birth control and have a negative pregnancy test prior to inclusion.
Key Trial Info
Start Date :
April 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 3 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04070508
Start Date
April 1 2023
End Date
November 3 2025
Last Update
March 17 2023
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