Three-Dimensional Printing of Navigational Template in Localization of Small Pulmonary Nodule: A Prospective, Randomized, Controlled, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Accuracy of Lung Nodule Localization
研究概览
简要总结
The trial is to evaluate the efficacy and safety of three-dimensional printed navigational template in the clinical application of small peripheral lung nodule localization.
详细描述
Localization of small lung nodule is challenging due to the difficulty of nodule recognition during VATS. A three-dimensional printed navigational template was designed to aid percutaneous lung nodule localization, and its feasibility has been confirmed in previous study. The trial was conducted to confirm the non-inferiority of template-guided method to conventional CT-guided method in terms of localization accuracy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 19 to 80 years
- •lesions located in peripheral lung tissue which can be removed by wedge resection
- •The maximum diameter of the lesion is no more than 20 mm.
- •Research assistant consulted with the patient's surgeon to confirm the necessity of lung nodule localization
- •Informed consent was signed voluntarily.
排除标准
- •nodule located in the scapula region.
- •there were two or more lung nodules needed to be localized.
研究组 & 干预措施
CT-guided localization
This group of participants received conventional CT-guided lung nodule localization.
干预措施: CT-guided localization (Other)
template-guided localization
Three-dimensional printed template was customized based on participant's computed tomography information. Participants received template-guided lung nodule localization.
干预措施: template-guided localization (Device)
结局指标
主要结局
Accuracy of Lung Nodule Localization
时间窗: From the time of completing final CT scan, assessed up to 2 days.
Localization accuracy was defined by the localizer deviation between the hookwire and the center of the target nodule. (The deviation was measured using CAD software after downloading the CT images from the Picture Archiving and Communication Systems.)
次要结局
- Procedural Duration of the Nodule Localization(From the time of completing final CT scan, assessed up to 1 hour.)
- Radiation Dose(From the time of completing final CT scan, assessed up to 1 hour.)
- Complication Rate(From the time of completing final CT scan, assessed up to 2 days.)
研究者
Chang Chen
Chief of thoracic surgery
Shanghai Pulmonary Hospital, Shanghai, China