Using the Non Invasive Technology Magnetic Resonance Elastography for the Diagnosis of Liver Fibrosis Stage
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Liver Biopsy Result for liver fibrosis grade
研究概览
简要总结
This study evaluates the ability of Magnetic Resonance Elastography non invasive technology to identify the liver fibrosis stage in patients with chronic liver diseases compared to Shear Wave Elastography and/or Liver Biopsy.
详细描述
Recent advances in magnetic resonance imaging (MRI) of the liver have led to improvements in diagnosis of chronic liver diseases. Detection and staging of liver fibrosis has become important; however, until about the last decade, it depended on an invasive liver biopsy. Liver biopsy is limited by high cost, low patient acceptance, interobserver variability during microscopic evaluation, sampling error, poor reproducibility, and, importantly, an invasive nature with a complication rate of 3% and a mortality rate of 0.03%. With the emergence of elastography techniques, the need for liver biopsy has rapidly diminished for diagnosis of clinically significant liver fibrosis. Magnetic Resonance Elastography has gained increasing popularity in recent years, in large part due to its higher technical success and ability to overcome some of the weaknesses of ultrasound-based methods for assessing liver fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic liver diseases
排除标准
- •Patients who don't have chronic liver diseases
研究组 & 干预措施
Liver biopsy ,Elastography and MRE
Performance of routine Liver biopsy,Shear Wave Elastography and investigational MRE (Magnetic Resonance Elastography) in order to evaluate liver fibrosis stage.
干预措施: MRE (Magnetic Resonance Elastography) (Device)
Elastography and MRE
Performance of routine Shear Wave Elastography and investigational MRE (Magnetic Resonance Elastography) in order to evaluate liver fibrosis stage.
干预措施: MRE (Magnetic Resonance Elastography) (Device)
结局指标
主要结局
Liver Biopsy Result for liver fibrosis grade
时间窗: Patient will undergo Liver biopsy once during 1 year of the study.
Liver Fibrosis score measured by Metavir scale .The Metavir score grades the degree of fibrosis on a 5-point scale from 0 to 4. The activity, which is the amount of inflammation (specifically, the intensity of necro-inflammatory lesions), is graded on a 4-point scale from A0 to A3. Fibrosis score: F0 = no fibrosis F1 = portal fibrosis without septa F2 = portal fibrosis with few septa F3 = numerous septa without cirrhosis F4 = cirrhosis Activity score: A0 = no activity A1 = mild activity A2 = moderate activity A3 = severe activity Liver biopsy will be perfomed only according to physician recommendation.
Magnetic Resonance Elastography (MRE) Result for liver fibrosis grade
时间窗: Patient will undergo Magnetic Resonance Elastography (MRE) once during 1 year of the study.
Liver Fibrosis score determined by liver stiffness in 4 fibrosis grades: \>1=any fibrosis, \>2=significant fibrosis, \>3=advanced fibrosis, 4=cirrhosis
Shear Wave Elastography Result for liver fibrosis grade
时间窗: Patient will undergo Shear Wave Elastography once during 1 year of the study.
Liver Fibrosis score determined by liver stiffness in in 5 fibrosis grades: 0=no fibrosis, \>1=any fibrosis, \>2=significant fibrosis, \>3=advanced fibrosis, 4=cirrhosis
次要结局
未报告次要终点
研究者
Prof. Ziv Ben-Ari MD
Head of Liver Diseases Center
Sheba Medical Center