The Role of Real Time Elastography in the Noninvasive Assessment of Liver Fibrosis in Chronic Viral Hepatitis
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Real Time Elastography result
研究概览
简要总结
AIM To evaluate the role of real time elastography (ARFI and Hitachi elastography) in noninvasive diagnosis of liver fibrosis in patients with chronic hepatitis
详细描述
INTRODUCTION
Establishing liver fibrosis grade in patients with chronic viral hepatitis is very important for the prognostic assessment and in making the decision to initiate antiviral treatment. Although the liver biopsy remains the gold standard, recent studies focused on establishing the role of noninvasive methods in liver fibrosis grading.
Elastography is an imaging method which estimates tissue elasticity. The first elastography method which appeared was Transient Elastography (TE), followed by Real Time Elastography (RT-E) and Acoustic Radiation Force Impulse (ARFI). TE was a method especially developed for noninvasive assessment of liver fibrosis as an alternative to liver biopsy. Unlike these, RT-E and ARFI have multiple applications in diffuse and tumoral pathology.
Transient Elastography (FibroScan) represents a noninvasive method useful in detecting the degree of liver fibrosis. The ultrasound transducer probe is able to generate elastic shear waves that propagate through the liver tissue as well as to measure their speed in the tissue. Wave speed is directly related to tissue stiffness which is expressed in kilopascals [1]. Initially, this method was validated for use and considered for chronic hepatitis management guidelines, then for human immunodeficiency virus/hepatitis C virus (HCV) co-infection and cholestatic liver diseases. FibroScan failures to give reliable results in obese patients were reduced by developing a new XL probe which facilitated an alternative noninvasive method to liver biopsy for liver fibrosis assessment [2].
Acoustic Radiation Force Impulse (ARFI) was proposed as an alternative to FibroScan for the assessment of liver tissue elasticity, using a conventional ultrasound machine. The main advantages of this method are the possibility of producing real-time images and its feasibility in patients with ascites. Preliminary studies show better results for predicting advanced grades of liver fibrosis than for mild to moderate fibrosis where the method is less sensitive [3].
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
- 是
入选标准
- •age over 18 years old
- •Study will include three groups of patients as follows:
- •Group I: patients with chronic hepatitis B or C (defined by the presence of serum anti HCV antibody or serum hepatitis B surface antibody)
- •Group II (the control group): healthy adult volunteers
- •Group III: patients with hepatic cirrhosis type B or C
- •There at least one reference method available for patients with chronic hepatitis (Transient elastography/ liver biopsy)
- •Hepatic cirrhosis diagnosis is established using clinical and paraclinical features (ultrasonography, superior digestive endoscopy)
- •A written informed consent is given to each patient
排除标准
- •Patients with contraindication for elastography (pregnant women or who are breastfeeding) and patients with pacemakers
- •Patients with liver disease of other etiology than viral infection (autoimmune hepatitis, primary biliary hepatitis, primary sclerosing cholangitis, hemochromatosis, alfa 1-antitrypsin deficiency, or Wilson's disease)
- •History of alcohol abuse (alcohol intake> 20g/day)
- •Patients under treatment with hepatotoxic drugs (methotrexate, amiodarone, corticotherapy , chemotherapy, hormonotherapy)
- •Patients with technically unfeasible TE: patients with ascites
结局指标
主要结局
Real Time Elastography result
时间窗: up to 24 weeks
Value of real time elastography recordings for the evaluation of liver fibrosis.
次要结局
未报告次要终点
研究者
Dan Gheonea
MD, PhD, MSc Specialist in Gastroenterology
University of Medicine and Pharmacy Craiova