NCT04533932Unknown不适用
Endosonographic Real-time and Shear Wave Elastography to Assess Liver stiffness-a Pilot Study
Midwest Biomedical Research Foundation1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Degree of fibrosis
研究概览
简要总结
This is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy and safety of endosonographic real-time Elastography and shear wave Elastography with the current standards of care, i.e. liver biopsy and Vibration-controlled transient elastography (Fibroscan). Subjects who are referred for an endoscopic ultrasound (EUS) guided liver biopsy will be prospectively enrolled to undergo liver biopsy, Elastography and/or Vibration-controlled transient elastography.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Patients referred for EUS guided liver biopsy
- •Elevated liver enzymes without obvious etiology, thus necessitating liver biopsy or clinical concern for cirrhosis or NASH requiring histological confirmation
- •Ability to provide informed consent and willing to participate
排除标准
- •Clinical evidence of cirrhosis which obviates need for liver biopsy
- •Noninvasive lab testing which confirms presence of cirrhosis
- •Surgically altered foregut anatomy which precludes safe endoscopic liver biopsy
- •Coagulopathy with INR greater than 1.6 in patients on anticoagulant therapy
- •Thrombocytopenia with platelet count less than 50,000/mL
- •Pregnancy (positive urine pregnancy test in females of childbearing age)
- •Lack of consent
结局指标
主要结局
Degree of fibrosis
时间窗: through study completion, an average of 1 year
Degree of fibrosis based on histological assessment
次要结局
未报告次要终点
研究者
Divyanshoo Kohli, MD
Director of Endoscopy
Kansas City Veteran Affairs Medical Center
研究点 (1)
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