Prospective Study: Early Detection of Advanced Fatty Liver Disease in the General Adult Population by Using Non-Alcoholic Fatty Liver Disease Score and Elastography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Non-Alcoholic Fatty Liver Disease Score
研究概览
简要总结
Non-alcoholic fatty liver disease is the most common cause of chronic liver disease in the western world, affecting one in every three subjects.
The investigators hypothesize that a patient population without known liver disease has a certain percentage of patients with liver fibrosis who are undiagnosed and not monitored.
详细描述
The investigators will run an algorithm for the non-invasive diagnosis of advanced fibrosis in non-alcoholic fatty liver disease on a participants without known liver disease.
Nafld Score and Elastography are now being used to predict the severity of liver fibrosis and deciding whether the patient is going to a biopsy, clinical follow-up or further investigation of liver cirrhosis and complications.
The detection of participants with Nafld Score more than 0.675 (advanced fibrosis) will enroll them to an elastography test. Participants with advanced fibrosis according to elastography will be introduced to follow-up and treatment that should delay or prevent progression of the disease to more advanced conditions like: cirrhosis, portal hypertension, esophageal varicose veins and hepatocellular carcinoma.
If the investigators find that the results of the study are consistent with their hypothesis, this will lead to applying the flowchart to a larger sample of population in order to use it as a future survey.
Moreover, the investigators will check whether there is a correlation between Nafld Score and elastography in participants without know liver disease with Nafld Score more than 0.675.
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
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 45-60 who belong to an initial clinic which was chosen arbitrarily.
- •Subjects without known liver disease.
- •Subjects agree to sign a consent form. -
排除标准
- •History of right-sided heart failure
- •History of liver disease including positive infectious serology for hepatitis B or C
- •Pregnant women
- •People incapable of judgment -
结局指标
主要结局
Non-Alcoholic Fatty Liver Disease Score
时间窗: Up to five minutes
Non-alcoholic fatty liver disease Score (Nafld Score) is a non-invasive scoring system based on several laboratory tests that helps to estimate the amount of scarring in the liver. The score is made up of six parameters: age, BMI(body mass index), aspartate aminotransferase(AST) / alanine transaminase(ALT), platelet count, impaired fasting glucose(IFG), albumin. The Nafld Score formula is: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m\^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelets (×10\^9/l) - 0.66 × albumin (g/dl). 2 cutoff points were selected to identify the presence (\> 0.675) and absence (\< -1.455) of significant fibrosis. \< -1.455: predictor of absence of significant fibrosis (F0-F2 fibrosis), negative predictive value 93% . between -1.455 and 0.675: indeterminate score. \>0.675: predictor of presence of significant fibrosis (F3-F4 fibrosis), positive predictive value of 90%. The score will be calculated for all the participants.
次要结局
- Elastography Test(Up to two hours)
研究者
Rawi Hazzan
Head of Liver Unit
HaEmek Medical Center, Israel