Early Detection of Advanced Liver Fibrosis in Patients With Excessive Alcohol Intake
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Advanced fibrosis and cirrhosis assessed by FibroScan
研究概览
简要总结
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 environmental, genetic and epigenetic factors that could influence the development of advanced fibrosis.
The investigators will include patients 21 years of age or older with excessive alcohol intake, with abnormal AST, ALT, GGT and/or bilirubin, and without any evidence of decompensated liver disease (jaundice, ascites, encephalopathy).
Liver fibrosis will be estimated by FibroScan®. A designed questionnaire for studying environmental and psychosocial factors will be filled by the included patients, and blood samples will be obtained to study genetic and epigenetic factors.
The patients with advance fibrosis will be referred to the specialist for surveillance and treatment according to current clinical guidelines.
详细描述
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 disease (ALD) is a main cause of advanced liver fibrosis globally. ALD encompasses a range of disorders including simple steatosis, alcoholic steatohepatitis, fibrosis, cirrhosis, and hepatocellular carcinoma. In addition, patients with underlying ALD and active drinking can develop an episode of acute-on-chronic liver injury called "alcoholic hepatitis", which portends a poor prognosis.
Most patients with ALD are identified during the late stages of the disease when liver decompensation occurs. In fact, a recent global epidemiologic study (GLADIS) showed that ALD is by far the liver disease that is detected at the latest stages (ratio of early/late referral negative 8-fold). These results strongly suggest that there is a dire need for the early detection of ALD patients, which currently is almost nonexistent.
A non-invasive method to screen for advanced fibrosis and cirrhosis is transient elastography (FibroScan®). This modality could potentially diagnose silent liver disease among heavy drinkers, allowing for earlier referral to a specialty liver clinic for further treatment.
Individual susceptibility to the development of advanced fibrosis among heavy drinkers is likely determined by a combination of environmental, genetic and epigenetic factors, yet the mechanisms are largely unknown.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Advanced fibrosis and cirrhosis assessed by FibroScan
时间窗: baseline
Prevalence of advanced liver fibrosis and cirrhosis among patients with excessive alcohol intake using FibroScan. Cut-off value for advanced fibrosis (F3) \>8 kPa.
次要结局
未报告次要终点
研究者
Ramon Bataller
Principal Investigator
University of Pittsburgh