Navigational Bronchoscopy and Transthoracic Needle Biopsy for the Diagnosis of Peripheral Pulmonary Nodules: A Safety and Feasibility Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Feasibility
研究概览
简要总结
The goal of this study is to evaluate the feasibility and safety of navigation guided virtual transthoracic needle biopsy combined with navigational bronchoscopy for the diagnosis of peripheral pulmonary nodules (PPN).
详细描述
Accessing peripheral pulmonary nodules is problematic because they are often not visible endobronchially, not large enough to be visualized by x-ray fluoroscopy for transbronchial biopsy (TBBx), and/or do not lie within an accessible airway. In this study, investigators hope to evaluate new technologies to aid in PPN biopsy using navigation bronchoscopy (NB) combined with navigation transthoracic needle aspiration (N-TTNA) sampling of a PPN.
Patients meeting inclusion criteria who consent will undergo a convex Endobronchial Ultrasound (EBUS) bronchoscopy for evaluation and sampling of the mediastinum and hilum. Following this, NB will be performed with an ultrathin bronchoscope (4mm outer diameter with a 2 mm working channel) with R-EBUS and fluoroscopy. If the lesion is localized by NB and/or radial EBUS in conjunction with NB, TBBX will be taken. At the conclusion of TBBX sampling, a fluoroscopic evaluation to assess for the presence of pneumothorax will be performed and if one is present, appropriate clinical measures will be taken at the discretion of the treating team (tube thoracostomy, observation, etc.) and no further sampling techniques will be utilized. If the lesion was not able to be localized via NB and/or the physician feels insufficient sample was acquired for diagnosis and there is no evidence of pneumothorax, the patient will undergo N-TTNA at the same PPN during the same procedure time. It is envisioned that between 8-12 patients will require a N-TTNA to complete diagnosis.
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 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Target patient population: Patients with a peripheral pulmonary nodule as identified on CT chest ≤3cm from the pleura will be recruited. A PPN will be defined as a lesion >10mm and <3cm in diameter surrounded by lung parenchyma on CT chest. The decision for biopsy of the PPN will be made by the treating physician and agreed upon by the patient.
- •Participants must be at least 18 years old or older
- •No bleeding disorders
- •Provide informed consent.
排除标准
- •less than 18 years
- •lack of fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
- •inability to give informed consent
研究组 & 干预措施
Assessing peripheral pulmonary nodules
To evaluate the feasibility and safety of a procedure path including convex Endobronchial Ultrasound (EBUS) lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).
干预措施: Navigation guided bronchoscopy (Device)
结局指标
主要结局
Feasibility
时间窗: Immediately following procedure
Feasibility assessed by number of participants with successful completion of biopsy (i.e. a biopsy was able to be obtained to collect a tissue sample)
Incidence of Pneumothorax
时间窗: Immediately after procedure
Presence of pneumothorax assessed in participants with successful completion of biopsy.
次要结局
- Positive Diagnostic Yield of Bronchoscopic Biopsy of ETTNA + EBUS + NB(Approximately 1 week upon receipt of pathology report)
- Positive Diagnostic Yield of Bronchoscopic Biopsy of Electromagnetic Guidance Trans-thoracic Needle Aspiration (ETTNA) Alone(Approximately 1 week upon receipt of pathology report)
