Combining MRI Steatosis Assessment and Transient Elastography to Improve Liver Fibrosis Diagnosis in Non-Alcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 9
- 主要终点
- Comparison of the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD
研究概览
简要总结
The main objective is to compare the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD.
详细描述
No alcoholic fatty liver disease (NAFLD) is induced by an abnormal build up of fat in the liver. It can induce liver damage, namely fibrosis, which leads to cirrhosis and an increased risk of liver cancer. The diagnosis of liver fibrosis is thus critical to identify patients at risk.
Liver biopsy is the gold standard for the diagnosis of liver fibrosis. However this invasive test is expensive and has a significant morbidity.
To avoid this others non invasive test have been developed to assess steatosis and fibrosis of the liver :
- Magnetic Resonance Imaging can quantify liver steatosis accurately.
- Transient elastography (Fibroscan®) is approved for the diagnosis of fibrosis in chronic hepatitis C. However results in NAFLD were disappointing. Further, steatosis by heightening liver elasticity is thought to be the cause of these poor results.
- Several biological tests or score are also approved in chronic hepatitis C, but not in NAFLD.
The hypothesis driving this study is that by accounting for liver steatosis through the mean of MRI, we could more accurately interpret transient elastography value to accurately diagnose the severity of liver fibrosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years old
- •For which a liver biopsy is indicated for NAFLD according to current guidelines
- •Presenting with at least one of the metabolic syndrome criteria:
- •BMI > 25 kg/m² and/or Waist circumference ≥ à 94cm for men / ≥ à 80cm for women
- •Fasting glucose > or = to 5,6 mmol/L or diabetes / or lowering glucose treatment
- •Blood pressure ≥ 130/85 mmHg / or treatment
- •Triglycerides ≥ than 1,7 mmol/L
- •HDL-C ≤ than 1 mmol/L (men), ≤ 1,3 mmol/L (women) /or lipid lowering treatment
- •Affiliated to medical care insurance
- •Having signed informed consent for participating in the study
排除标准
- •Associated other chronic liver disease : infectious, auto immune, genetic
- •Alcohol consumption higher than 21 standard unit per week for men, or 14 standard unit for women;
- •Steatosis inducing treatment: steroids, amiodarone, methotrexate, tamoxifen
- •History of bariatric surgery
- •Contra indication to MRI (pace maker, metallic foreign body, claustrophobia)
- •Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
结局指标
主要结局
Comparison of the accuracy of transient elastography taking into account liver steatosis determined by MRI, to liver biopsy for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD
时间窗: Day 1
Determination of the fibrosis stage by a double blind reading of liver biopsy by experienced pathologist
次要结局
- Assessment of accuracy of transient elastography corrected according to the degree of liver steatosis determined by MRI for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD compared to liver biopsy(Day 1)
- Assessment of accuracy of transient elastography taking into account liver steatosis determined by MRI, for the diagnosis of liver fibrosis at all fibrosis stage (F1-F2-F3-F4) in patient with NAFLD compared to liver biopsy(Day 1)
- Assessment of accuracy of transient elastography corrected according to the degree of liver steatosis determined by MRI for the diagnosis of liver fibrosis at all fibrosis stage (F1-F2-F3-F4) in patient with NAFLD compared to liver biopsy(Day 1)
- Assessment of accuracy of Acoustic Radiation Force Impulse for the diagnosis of liver fibrosis ≥F2 in patient with NAFLD compared to liver biopsy(Day 1)