Transthoracic Needle Biopsy for the Diagnosis of Pulmonary Nodule Using Three-dimensional Printed Navigational Template: A Phase I Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Success rate of needle insertion
研究概览
简要总结
This study evaluates the feasibility of three-dimensional printed template in transthoracic pulmonary nodule biospy. Investigator planned to include 20 patients with lung nodule biopsy schedule to receive template-guided transthoracic needle aspiration.
详细描述
In previous study,a navigational template has been created to simplify the procedure of preoperative lung nodule localization. It was reported that localizer deviation was 10(0-20)mm.In this trial,Investigator explores the utility of this navigational template in transthoracic lung nodule biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CT confirmed peripheral lung nodule; Nodule size larger than or equal to 3 cm; ECOG Performance Status 0-2 ; Informed consent.
排除标准
- •Nodule located in the scapula region wherein biopsy needle is impeded; Nodule within 3 cm above diaphragmatic dome.
结局指标
主要结局
Success rate of needle insertion
时间窗: 15 minutes
Clinician evaluate the relative position between biopsy needle and the target lesion on CT images after needle insertion.
次要结局
- procedural length(1 hour)
- radiation dosage(1 hour)
研究者
Chang Chen
Prof. Dr.
Shanghai Pulmonary Hospital, Shanghai, China