Screening in Primary Care of Advanced Liver Fibrosis in NAFLD and/or Alcoholic Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,788
- 试验地点
- 13
- 主要终点
- Sensitivity of the Fibrometer test for advanced liver fibrosis
研究概览
简要总结
The primary objective of the SOPRANO study is to compare two blood fibrosis tests, the eLIFT and the FibroMeter, for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers.
详细描述
Chronic liver diseases (CLD) are responsible for 17 000 deaths each year in France (cirrhosis: 8 000, liver cancer: 9 000). Non-alcoholic fatty liver disease (NAFLD) and alcoholic liver disease (ALD) are the two main causes of CLD in France, affecting respectively 25% and 12% of the adult general population. A subset of these patients develops advanced liver fibrosis (ALF), which requires referral to the specialist for specific evaluation and management to avoid the occurrence of cirrhosis and its life-threatening complications. General practitioners (GPs) are the first-line physicians in front of the large population of NAFLD and/or ALD patients. It is very difficult for GPs to identify the patients who develop ALF and require referral to the specialist, as their physical examination, usual biology and ultrasonography remain normal.
The non-invasive diagnosis of liver fibrosis is now available with elastography devices and blood tests. Elastography is a very accurate method but it is available only in few specialised centers. Specialised blood tests are available to all physicians, but they are quite expensive and not reimbursed with therefore limited use in clinical practice. Consequently, liver fibrosis remains unevaluated in most patients with NAFLD and/or ALD, which explains why a lot are too late diagnosed at the stage of cirrhosis complications with poor short-term survival.
The eLIFT isa new blood fibrosis test specifically dedicated for GPs with simple parameters and easy "by head" calculation. The simple eLIFT was compared with the specialised blood test FibroMeter for the diagnosis of ALF in an cohort of 1024 biopsy-proven NAFLD and/or ALD patients. eLIFT was little less accurate than FibroMeter (AUROC: 0.78 vs 0.81). Using the recommended cut-offs (eLIFT ≥8, FibroMeter ≥0.46), eLIFT was more sensitive than FibroMeter (86% vs 77%), whereas FibroMeter was highly more specific (71% vs 51%). These results position eLIFT and FibroMeter as interesting tools for the screening of ALF in large populations.
As the preliminary results come from very selected patients, i.e. patients from tertiary centers who underwent a liver biopsy, it's necessary nox to evaluate in the real condition of primary care setting whether the use of eLIFT or FibroMeter will help GPs to screen ALF in their asymptomatic NAFLD and ALD 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
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NAFLD and/or ALD patient defined by at least 1 of the following criteria:
- •Excessive alcohol consumption: higher than 210 g / week (men), or 140 g / week (women)
- •Type 2 diabetes
- •at least 2 metabolic factors among BMI higher than or equal to 25 kg / m 2; Elevated blood pressure (antihypertensive drug, or systolic blood pressure higher than or equal to 130mmHg, or diastolic blood pressure higher than or equal to 85mmHg), Dyslipidemia (lipid-lowering drug, or HDL cholesterol lower to 40mg/dl (men) / 50mg/dl (women), or triglycerides higher than or equal to150mg/dl); Hyperferritinemia (higher than upper limit of normal from the laboratory)
- •Bright liver at ultrasonography without steatosis-inducing drug(systemic corticosteroids, tamoxifen, amiodarone, methotrexate)
- •Following a protocol amendment, the 3 last investigating primary care centres will include NAFLD and/or ALD patients according to these updated criteria:
- •Excessive alcohol consumption: >210 g/week in men or >140 g/week in women,
- •AND/OR type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments,
- •AND with the following stratification:
- •30% with excessive alcohol consumption 65% with type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments 5% with both conditions (excessive alcohol consumption, AND type 2 diabetes treated with insulin and/or at least two other anti-diabetic treatments)
- •Patient's agreement to have a blood sample collected in a local laboratory participating in the study
- •Subjects covered by or having the rights to medical care assurance
- •Written informed consent obtained from subject
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
- •Pregnancy, breastfeeding
- •Persons in detention by judicial or administrative decision
- •Person admitted to a health or social establishment for purposes other than research
- •Person subject to a legal protection measure
- •Person unable to express consent
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: eLIFT (Diagnostic Test)
结局指标
主要结局
Sensitivity of the Fibrometer test for advanced liver fibrosis
时间窗: 1 day
Rate of patients with advanced liver fibrosis correctly identified by the Fibrometer test
Sensitivity of the eLIFT test for advanced liver fibrosis
时间窗: 1 day
Rate of patients with advanced liver fibrosis correctly identified by the eLIFT test
次要结局
- rate of patients referred to the specialist following the screening procedure, with eLIFT test(1 day)
- eLIFT and FibroMeter screening procedures as a function of the cause of the underlying liver disease (NAFLD, ALD, or mixed NAFLD+ALD)(1 month)
- the accuracy of a sequential strategy using eLIFT as first-line test and FibroMeter as second-line test(1 day)
- most relevant risk factor of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care(1 day)
- rate of patients referred to the specialist following the screening procedure, with FibroMeter test(1 day)
- Rate of "unnecessary referrals" to the specialist with eLIFT test(1 month)
- Rate of "unnecessary referrals" to the specialist with Fibrometer test(1 month)
- Number of gastroesophageal varices at risk of bleeding detected following the screening procedure, with comparison between eLIFT and FibroMeter strategies(1 month)
- directs costs by type of disease such as ALF, hepatocellular carcinoma, gastroesophageal varices at risk of bleeding with comparison between eLIFT and FibroMeter strategies(1 month)
- Number of hepatocellular carcinoma adetected following the screening procedure, with comparison between eLIFT and FibroMeter strategies(1 month)
- specialized blood test ELF for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers(1 day)
- patient adherence to the screening of advanced liver fibrosis(1 month)
- Camden and Islington pathway (FIB4 then ELF) for the screening of advanced liver fibrosis in patients with NAFLD and/or ALD from primary care centers,(1 day)
- Camden and Islington pathway , with comparison of sequential strategy eLIFT then FibroMeter(1 day)