Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Number of patients with a biopsy sample adequate for pathology interpretation
研究概览
简要总结
Background: Retroperitoneal tumors are typically large and inhomogeneous, with a variable amount of necrosis within the tumor mass which decreases the diagnostic yield of biopsy (false negative or inadequate).
Rationale: Real-time contrast enhancement can highlight the viable tumoral tissue and avoid the necrotic area.
Aims: To compare contrast-enhanced ultrasound (CEUS) guidance and conventional (B-mode) ultrasound (US) guidance in terms of diagnostic yield, need for repeat biopsy, and rate of adverse events.
Methods: A consecutive series of patients with previously documented retroperitoneal tumors and indications for percutaneous biopsy were randomly assigned to benefit from the standard of practice B-mode US-guided biopsy or CEUS-guided biopsy.
The diagnostic accuracy, need for repeat biopsy, and adverse events were noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •All patients with retroperitoneal tumors with indication for percutaneous biopsy
排除标准
- •Tumors inaccessible for ultrasound guided biopsy
- •Standard contraindications for biopsy (altered coagulation tests, poor performance status)
- •Lack of written informed consent
结局指标
主要结局
Number of patients with a biopsy sample adequate for pathology interpretation
时间窗: 4 weeks
次要结局
- Number of patients with procedural-related adverse events(One week)
- Number of patients requiring a second biopsy due to prior inadequate sampling(6 weeks)
研究者
Rareș Crăciun
Principal Investigator
Iuliu Hatieganu University of Medicine and Pharmacy