Acoustic Radiation Force Impulse Imaging (ARFI) : a New Technique to Assess Liver Elasticity - Norms in ARFI: Distribution and Reproducibility of ARFI Values in Disease-free Livers or Pathological Livers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- The elasticity parameter will be for each patient the median of ten ARFI values (m/s) in the right liver.
研究概览
简要总结
Liver stiffness measurement (LSM) by non invasive methods is increasingly used to estimate liver fibrosis in patients with chronic liver diseases. However, there is growing evidence that fibrosis is not the only determinant of liver stiffness. Indeed inflammation, cholestasis, congestion could also interfere with stiffness measurements. Acoustic radiation force impulse imaging (ARFI) is a new technology to perform real time LSM. Using a standard ultrasonographic probe, it offers elastography with a flexible metering box at variable depth, allowing the examination of specific area.
详细描述
There are many causes of chronic liver diseases such as hepatitis C infection, hepatitis B infection, alcohol, NAFLD (non-alcoholic fatty liver disease), drugs and auto-immune liver disease.
Although the causes differ the pathological response to injury tends to be similar leading to fibrosis and cirrhosis.
Liver biopsy is the current gold standard for the assessment of liver fibrosis but is poorly suited for active monitoring because of its expense and morbidity. Thus, development of alternatives that are safe, inexpensive, and reliable is a priority.
Liver stiffness measurement (LSM) by non invasive method is increasingly used to estimate liver fibrosis in patient with chronic liver disease. Acoustic radiation force impulse imaging (ARFI) is a new technology to perform real time LSM. Using a standard ultrasonographic probe, it offers elastography with a flexible metering box at variable depth, allowing the examination of specific area.
The purpose of this work was to evaluate by ARFI, the efficiency of this new technique, the reproducibility inter and intra observer, and the liver elasticity obtained by this method in different patient groups.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Man or Woman
- •Age> 18 years old
- •Able to understand the study and to give informed consent
- •Informed consent signed by patient and investigator before any study required examination
- •With a valid health insurance
- •Groups specific inclusion criteria are:
- •Group A : healthy volunteers without known liver disease
- •Group B : voluntary patients without known liver disease
- •Group C and D Patient with a diagnosed chronic liver disease
- •Group E : patients with liver tumors (benign or malignant) with surgical indication
- •Group F : patients with acute right heart insufficiency diagnosed by a cardiologist
- •Group G :patients with biliary cholestasis and imaging evidence of biliary dilatation
排除标准
- •Patient under 18 years old
- •Not able to understand the study or to give their consent.
- •Pregnant woman
- •Severe respiratory insufficiency
- •Unable to perform a "light" apnea .
- •hemodynamic instability (cardiogenic shock, septic or anaphylactic) possibility of disruption of the elasticity and inability to carry patient.
- •Chronic heart insufficiency.
- •deprived of their liberty by court
研究组 & 干预措施
Group A
healthy volunteers
干预措施: ARFI measurement (Device)
Group B
patients with supposed disease free liver (normal hepatic and pancreatic biochemistry)
干预措施: ARFI measurement (Device)
Group D
patients with cirrhosis
干预措施: ARFI measurement (Device)
Group E
patients with liver tumour and surgery indication
干预措施: ARFI measurement (Device)
Group F
patients with reversible liver diseases and with acute left cardiac insufficiency
干预措施: ARFI measurement (Device)
Group C
patients with non cirrhotic hepatopathy
干预措施: ARFI measurement (Device)
Group G
patients with reversible liver diseases and with biliary cholestasis
干预措施: ARFI measurement (Device)
结局指标
主要结局
The elasticity parameter will be for each patient the median of ten ARFI values (m/s) in the right liver.
时间窗: One or two 30 min visit according to the patient group
次要结局
- Median (m/s) of ARFI values between before and after effective treatment for liver reversible disease(From patient admission until patient healing in groups F&G.)
- Inter and intra observer reproducibility(Three 30 min visits in healthy volunteer group.)