SCREaning of Advanced Liver Fibrosis Using Non-Invasive Tests in General Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 391
- 试验地点
- 13
- 主要终点
- Proportion of advanced hepatic fibrosis.
研究概览
简要总结
The main objective of the study is to evaluate the pertinence of initiating screening for advanced hepatic fibrosis after a FIB4 result > 2.67 automatically calculated in the local laboratory and followed by a specialized hepatic evaluation.
详细描述
Chronic liver diseases are insidious diseases characterized by inflammation of the liver parenchyma responsible for a progressive accumulation of fibrosis until cirrhosis and hepatocellular carcinoma (HCC). Cirrhosis and HCC are respectively the 11th and 16th most frequent causes of death in the world, and are responsible for 2 million deaths each year. Cirrhosis and HCC are most often diagnosed too late with a median survival of 18-24 months.
The degree of hepatic fibrosis is the main predictive factor of the risk of hepatic complications (decompensation of cirrhosis, HCC) in chronic liver diseases.
Hepatic fibrosis is described in 5 stages from F0 (no fibrosis) to F4 (cirrhosis). It is well accepted that patients with advanced hepatic fibrosis (F3 and F4) are at the highest risk of developing complications of cirrhosis and/or HCC. It is therefore necessary to identify these patients in order to offer them specialized management.
Tests have been developed over the last two decades for the non-invasive diagnosis of liver fibrosis, essentially the fibrosis blood test (FIB4) and liver elastometry devices (fibroScan). The FIB4 is a simple blood test that is easy to calculate from the usual inexpensive blood parameters (ASAT, ALAT, platelets). The recommendations of French, European and American scientific societies are unanimous and recommend targeted screening for liver fibrosis in patients with hepatic risk factors using FIB4 as a first line test.
To facilitate screening by general practitioners, several French consortia of medical analysis laboratories have set up routine calculation of FIB4 on all biological tests, including platelets, AST and ALT, without regard to the patient's risk factors for liver disease. This approach is not in concordance with the recommendations of the scientific societies (targeted screening in patients with hepatic risk factors) and needs to be evaluated.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years
- •Blood sample taken at a medical testing laboratory selected for the study.
- •Biology without high risk of false positive result for FIB4 (AST and ALT ≤ 300 IU/l ; Platelets ≥ 50 G/l and < 500 G/l.)
- •FIB4 > 2.67 after automatic calculation in the medical laboratory less than 3 months old
- •Signature of informed consent to participate in the study
排除标准
- •Ongoing specialized follow-up for a chronic liver disease
- •Difficulty understanding the French language
- •Pregnant women, breastfeeding or parturient women
- •Persons suspended from liberty by judicial or administrative decision
- •Persons under legal protection
- •Persons unable to express their consent
- •Non affiliation to a social security system
研究组 & 干预措施
Diagnostic FIB4
Only one arm because diagnostic study evaluating blood test using elastometry and liver biopsy as reference
干预措施: FIB4 (Diagnostic Test)
结局指标
主要结局
Proportion of advanced hepatic fibrosis.
时间窗: 3 months maximum
The endpoint for this objective will be the diagnosis of advanced liver fibrosis is a stage of F3-4 fibrosis on liver biopsy (NASH-CRN classification), in patients with a FIB4\> 2.67 and a FibroScan result ≥ 8 kPa.
次要结局
- Determine the average cost spent on a patient diagnosed with advanced liver fibrosis(3 months maximum)
- Determine risk factors associated with advanced liver fibrosis, and consequently the subgroup of patients for whom screening should be a priority(3 months maximum)
- Determine the rate of patients with a significant liver complication in the population of patients with risk factors(3 months maximum)
- Determine the rate of patients requiring second-line evaluation by elastometry(3 months maximum)
- Determine the rate of patients requiring management by a liver disease specialist.(3 months maximum)
- Determine patient adherence to the screening procedure(3 months maximum)