Alcoholic Liver Disease
Conditions
Interventions
Alcoholic liver disease combined with hepatitis B:None
Alcoholic liver disease combined with metabolic-associated fatty liver disease:None
Alcoholic liver disease combined with other chronic liver diseases:None
Simple alcoholic liver disease.:None
Sponsors
Huadong Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years. 2. Meeting the diagnostic criteria for ALD according to either the 2024 American College of Gastroenterology Clinical Guideline: Alcohol-Associated Liver Disease or the Chinese 2019 Primary Care Guideline for Alcoholic Liver Disease: (1) History of long-term heavy alcohol consumption (male >=40 g/day, female >=20 g/day, for >=5 years) or history of heavy alcohol consumption (>80 g/day) within the past 2 weeks. (2) Elevated indicators such as AST, ALT, GGT, TBil, PT, MCV, with AST/ALT >2, elevated GGT, and elevated MCV being characteristic of ALD. These indicators generally return to normal within 4 weeks of alcohol abstinence (GGT recovery is slower). (3) Clinical manifestations: ranging from asymptomatic (early fatty liver, fibrosis) to symptoms of decompensated cirrhosis or alcoholic hepatitis, such as jaundice, ascites, and hepatic encephalopathy. (4) Liver imaging techniques: 1) Ultrasound diagnosis: Presence of 2 out of the following 3 abdominal ultrasound findings indicates diffuse fatty liver: diffuse enhancement of near-field echo in the liver, stronger than that of the kidney; gradual attenuation of far-field echo in the liver; unclear visualization of intrahepatic duct structures. 2) CT diagnosis: Diffuse decrease in liver density, with liver/spleen CT ratio <=1.0. The liver/spleen CT ratio can be used to assess the severity of ALD: mild (0.7 < liver/spleen CT ratio <=1.0), moderate (0.5 < liver/spleen CT ratio <=0.7), and severe (liver/spleen CT ratio <=0.5). (5) Exclusion of current hepatotropic virus infections, drug-induced liver injury, toxic liver damage, autoimmune liver diseases, etc. Patients meeting criteria (1), (2), (3), and (5), or criteria (1), (2), (4), and (5) can be diagnosed with ALD; those meeting only criteria (1), (2), and (5) are suspected cases of ALD; those meeting criterion (1) with evidence of current viral hepatitis infection can be diagnosed as ALD with viral hepatitis. 3. Relatively stable dietary habits, no major changes in diet structure, regular lifestyle, and similar drinking patterns, work environment, conditions, and job content. 4. With or without at least one of the following chronic liver diseases: (1) Chronic hepatitis B or C virus infection; (2) Metabolic dysfunction-associated steatotic liver disease (MASLD); (3) Other causes of chronic liver disease (participants deemed eligible by investigators, such as autoimmune liver disease, hereditary liver disease, drug-induced liver disease, etc.). 5. Voluntary participation in the study and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Participants post-liver transplantation 2. Those with other severe systemic diseases and an expected survival of <1 year 3. Individuals unable to cooperate with follow-up or with incomplete data 4. Pregnant or lactating women 5.History of malignancies other than hepatocellular carcinoma 6. Other participants deemed ineligible for the study by the investigator, such as those with HIV or syphilis requiring treatment, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demographic data: age, gender, ethnicity, occupation, alcohol use history, clinical information, etc.;Laboratory tests: liver function, renal function, complete blood count, coagulation function, virological markers, metabolic indicators, etc.;Imaging examinations: abdominal ultrasound, FibroScan, CT/MRI (if clinically indicated).;Liver biopsy (for participants requiring liver biopsy).;Quality of life assessment (SF-36 questionnaire).; | — |
Countries
China
Contacts
Public ContactChen Yuanwen
Huadong Hospital, Fudan University
Outcome results
None listed