A Prospective Study to Assess the Feasibility and Safety of a Wireless Palpator to Detect Occult Subpleural Lung Tumours in Humans During Minimally Invasive (VATS) Lung Resection.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 主要终点
- Tumour detection
研究概览
简要总结
Evaluation of the ability of the Palpator to detect hidden (occult) lung tumours that cannot be visualized or palpated using the traditional methods of visual inspection, grasper palpation, and VATS ultrasound.
详细描述
All procedures will be performed with the patient under general anesthesia with single lung ventilation through double-lumen endotracheal intubation. Three to four thoracoports, no larger than 12 mm, will be inserted in the intercostal spaces as needed. After VATS port placement, the pleural cavity will be insufflated with CO2 to a maximum pressure of 8 mm Hg to assist with lung deflation. A standard VATS pleuroscopy will be performed to visually search for the nodule and its position confirmed with sequential assessment using a grasper, the Palpator, the VATS ultrasound probe, and then finger palpation. This will ensure that all patients will have the opportunity to avoid a large thoracotomy if the lesion can't be identified by the Palpator. If the lesion can be detected either visually or by grasper palpation, this information will be recorded, but will be excluded from the analysis of Palpator feasibility.
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 > 18 years
- •Peripheral occult sub-pleural (>5 mm) solitary lung nodule < 50 mm on CT scan scheduled for surgical removal using a VATS approach
排除标准
- •Semi-solid nodules (ground glass nodule).
- •Pregnancy or potentially pregnant women.
- •Mentally challenged.
- •Inability to consent for the study.
- •Patients less than 18 years old.
- •Patients with pulmonary nodules easily located during VATS (> 50 mm, pleural puckering, invading chest wall)
- •Patients who have chest anatomy precluding VATS resection.
结局指标
主要结局
Tumour detection
时间窗: 1 day
The palpator will be declared feasible of it can detect at least 80% of tumours (sensitivity) without the need for a thoracotomy.
次要结局
- Adverse events(30 days)
- Prevention of thoracotomy(1 day)
研究者
Richard Malthaner
Chair Chief Thoracic Surgery
Lawson Health Research Institute