Comparison of FibroScan With Histological Evaluations of Liver Fibrosis in Patients With Hepatitis B and C Presenting for Liver Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 907
- 试验地点
- 4
- 主要终点
- Diagnosis Performance of VCTE for Determination of Cirrhosis (Metavir F4) in Patients With Chronic Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)
研究概览
简要总结
This study will examine the effectiveness of the FibroScan device in differentiating fibrosis in patients with hepatitis B and C. The FibroScan measures liver stiffness and will be correlated to the liver biopsy to see if it can diagnose the stage of liver disease. Patients who are scheduled to have a liver biopsy will also have a fibroscan and the stiffness will be correlated with the biopsy stage.
详细描述
STUDY OBJECTIVES:
Co -Primary Aims:
- Diagnosis of cirrhosis in patients with chronic viral hepatitis B and C;
- Correlation of the FibroScan measurement with Metavir liver fibrosis scores by differentiating no/mild fibrosis (F0-F1) from severe fibrosis (F2-F4).
STUDY DESIGN:
This is a multi-center study in which the FibroScan measurements will be collected prospectively from patients with chronic hepatitis B and C virus presenting for liver biopsy. The study duration will be 12 months. The study will initially have 3 investigational sites in the United States. Up to 3 more investigational sites may be identified to participate in the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Investigator unaware of biopsy results
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is able to give informed consent for this study and agrees to provide a blood sample.
- •Subject must be at least 18 years of age.
- •Subject has had or will have a liver biopsy for chronic liver disease, secondary to HBV or HCV or within 6 months of FibroScan (experimental cohort 1 only).
- •Subjects who have hepatitis C (HCV) or hepatitis B (HBV) should be treatment naïve or off interferon therapy or nucleoside/nucleotide analogs for HBV for a minimum of 3 months prior to the FibroScan and liver biopsy.
排除标准
- •Unable or unwilling to provide informed consent.
- •Confirmed diagnosis and/or history of malignancy, or other terminal disease.
- •Uninterpretable biopsy specimen.
- •Missing critical clinical, biochemical and/or demographic information.
- •Receiving anti-viral therapy for infection of HCV or HBV within 3 months prior to the FibroScan and liver biopsy.
- •Subject with other chronic liver disease, including Wilson's disease, alpha 1-antitrypsin deficiency, cholestatic liver disease, or hemochromatosis.
- •Patient with clinical ascites.
- •Patients with morbid obesity defined as a BMI of greater than or equal to
- •Patients who are pregnant.
- •Patients who have an implantable cardiac device such as defibrillator or pacemaker.
研究组 & 干预措施
Single Arm undergoing FibroScan
Single arm active comparison of biopsy to vibration controlled elastography
干预措施: FibroScan (Device)
结局指标
主要结局
Diagnosis Performance of VCTE for Determination of Cirrhosis (Metavir F4) in Patients With Chronic Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)
时间窗: 28 days
VCTE was used to diagnose cirrhosis F4 in 748 patients undergoing liver biopsy and VCTE within a 28 day time period.
Diagnostic Accuracy of VCTE for the Prediction of Metavir Fibrosis Scores by Differentiating no/Mild (F0/F1) From Severe Fibrosis (F2 - F4)
时间窗: Liver Biopsy and VCTE within a time frame of 6 months
95% CI for Metavir Fibrosis stage 0 -1 consistent with no or mild fibrosis compared to Metavir 2 - 4 which represents significant fibrosis or cirrhosis
次要结局
未报告次要终点
研究者
Nezam H. Afdhal
Professor of Medicine, Part-time
Beth Israel Deaconess Medical Center