NCT02966847已完成不适用
Assessment of Cone-beam Computed Tomography (CBCT) Assistance to Video-assisted Thoracoscopic Surgery
Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年5月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Assessment of CBCT
研究概览
简要总结
In the coming years, an increase in lung nodule resection is expected, particularly in Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a tool whose use is constantly spreading.
详细描述
The aim of this study is to evaluate the feasibility of using intraoperative CBCT to develop a new procedure for intraoperative localization of pulmonary nodules in video-assisted thoracoscopic surgery.
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
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
- •Age greater than or equal to 18;
- •patient with unique or multiple pulmonary lesions of a size ranging from 5 to 20 mm;
- •Complete preoperative assessment;
- •Patient receiving information about the protocol who did not indicate his/her opposition to participate;
- •Patient covered by a social insurance system
排除标准
- •Reoperation (history of ipsilateral thoracic surgery);
- •Inability to achieve or obtain a single-lung ventilation during surgery;
- •Adult subject to legal protection (trusteeship, guardianship);
- •Person deprived of liberty.
结局指标
主要结局
Assessment of CBCT
时间窗: the day following the acquisition
Ability to identify the lesion on CBCT images of unventilated lung. CBCT images are interpreted by 2 senior surgeons.
次要结局
- Feasibility of CBCT(At the end of the surgery)
- Assessment of image quality of lesions(the day following the acquisition)
- Assessment of global image quality(the day following the acquisition)
研究者
研究点 (2)
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