Performance of Acoustic Radiation Force Impulse-Imaging in Comparison to Transient Elastography for the Non-invasive Staging of Liver Fibrosis in Patients With Chronic Hepatitis C
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 10
- 主要终点
- Non-inferiority of AUROCs of Acoustic Radiation Force Impulse (ARFI)- Imaging to Transient Elastography (Fibroscan) for assessment of liver fibrosis in patients with chronic hepatitis C using liver biopsy as the reference standard.
研究概览
简要总结
This study will evaluate the effectiveness of Acoustic Radiation Force Impulse (ARFI)- Imaging compared to Transient Elastography (FibroScan) in differentiating liver fibrosis in patients with chronic hepatitis C. Patients who are scheduled to have a liver biopsy will also undergo ARFI and FibroScan testing. The liver biopsy will be used as the reference method. The target sample size is 433.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18-79 years old
- •Written consent
- •Chronic Hepatitis C infection
- •Liver biopsy planned or performed within the last six months
- •In addition, 10 patients/center with proven liver cirrhosis without present liver biopsy can be included
排除标准
- •Consuming illness (HIV infection, malignoma)
- •Comorbidities associated to HCV (HBV, NASH, hemochromatosis, primary sclerosing cholangitis, primary biliary cirrhosis
- •Antiviral therapy between liver biopsy and study inclusion
- •Pacemaker or heart defibrillator
- •Pregnancy or lactation
- •Liver transplantation
结局指标
主要结局
Non-inferiority of AUROCs of Acoustic Radiation Force Impulse (ARFI)- Imaging to Transient Elastography (Fibroscan) for assessment of liver fibrosis in patients with chronic hepatitis C using liver biopsy as the reference standard.
The diagnostic accuracy measured with the Area under the ROC curve (AUROC) is calculated for Acoustic Radiation Force Impulse (ARFI)- Imaging and Transient Elastography (Fibroscan) using histology obtained by liver biopsy as reference method in patients infected with chronic hepatitis C. The ROC curve represents sensitivity versus 1-specificity for all possible cut-off values for prediction of the different fibrosis stages, respectively. The areas under the curves (AUROC) as well as 95 % CI of AUROC are calculated.
次要结局
- Comparison of AUROC of ARFI-Imaging and Transient Elastography with FibroMax (liver fibrosis marker)
- Comparison of AUROC of ARFI and Transient Elastography with the European Liver Fibrosis-Group Marker (ELF)
- Evaluation of a combination of non-invasive methods for optimising AUROC for the assessment of liver fibrosis
- Evaluation of factors associated with measurement failure of ARFI-Imaging and Transient Elastography
- Assessment of center variability of results
研究者
Johannes Vermehren
MD
Johann Wolfgang Goethe University Hospital