Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients (IMPROVE Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- e-LIFT negative predictive value for the diagnosis of advanced hepatic fibrosis
研究概览
简要总结
The main objective is to determine the performance of the simple eLIFT blood test for advanced liver fibrosis screening in NAFLD and/or alcoholic patients in primary care.
详细描述
eLIFT, is a new blood fibrosis test specifically dedicated for general practitioners with simple parameters and easy "by head" calculation. Using the recommended cut-offs (eLIFT ≥8), eLIFT sensitivity was 86%. This result position eLIFT an as interesting tool for the screening of advanced liver fibrosis in large populations.
As our preliminary results come from very selected patients, i.e. patients from tertiary centres who underwent a liver biopsy, we now need to evaluate in the real condition of primary care setting whether the use of eLIFT will help general practitioners to screen advanced liver fibrosis in their asymptomatic NAFLD and alcoholic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NAFLD and/or alcoholic patient defined by ≥1 of the following criteria:
- •Excessive alcohol consumption: >210 g/week (men), >140 g/week (women)
- •Type 2 diabetes
- •≥2 metabolic factors among: 1/BMI ≥25kg/m2; 2/elevated blood pressure (antihypertensive drug, or systolic blood pressure ≥130mmHg, or diastolic blood pressure ≥85mmHg), 3/dyslipidemia (lipid-lowering drug, or HDL cholesterol <40mg/dl (men) / <50mg/dl (women), or triglycerides ≥150mg/dl); 4/hyperferritinemia (>300 ng/ml (men)/>200 ng/ml (women))
- •Bright liver at ultrasonography without steatosis-inducing drug
- •Obtaining the signature of the consent to participate in the study
排除标准
- •Already ongoing specialized follow-up for a chronic liver disease
- •Altered health status with poor short-term prognosis, not compatible with a screening procedure
- •Decompensated cirrhosis (hepatic encephalopathy, jaundice, ascites, variceal bleeding, hepatorenal syndrome)
- •Acute infection
- •Inadequate understanding of the French language
- •Pregnant, breastfeeding or parturient women
- •Persons deprived of their liberty by judicial or administrative decision
- •Persons subject to legal protection measures
- •Persons unable to consent
- •Refusal to participate
研究组 & 干预措施
Diagnostic Test: e-LIFT
only one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference
干预措施: e-LIFT (Diagnostic Test)
结局指标
主要结局
e-LIFT negative predictive value for the diagnosis of advanced hepatic fibrosis
时间窗: 1 day
The primary outcome of the study is the negative predictive value for the diagnosis of advanced hepatic fibrosis (i.e., the rate of patients who do not actually have advanced hepatic fibrosis when the eLIFT test is \<8)
次要结局
- sensibility of the eLIFT test(1 day)
- specificity and positive predictive value of the eLIFT test(1 day)
- rate of liver complications among patients with an eLIFT test ≥ 8(1 day)
- performance of e-LIFT test in subgroup analysis(1 day)