Comparing Diagnostic Yield of Real Time Cone Beam Computer Tomography Guided Electromagnetic Navigational Bronchoscopy With Cone Beam Computer Tomography Guided Robotic Navigational Bronchoscopy for Peripheral and Central Lung Lesions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Diagnostic Yield
研究概览
简要总结
Navigational bronchoscopy (NB) is used to access peripheral and central parenchymal lung lesions via endobronchial and transbronchial approach. Currently there are multiple platforms available to provide guidance to reach the peripheral and central lesions in the lung which are inaccessible via traditional video bronchoscopy. Traditionally NB is done under fluoroscopic guidance using C-arm but with development of Cone Beam CT and 3D reconstruction technology, fluoroscopy can be enhanced to much higher resolution and can also provide real time 3D augmentation of the lesion. It also enables the user to obtain a CT of the Chest to confirm the real time location of the lesion and the bronchoscopic biopsy catheter and instruments. This has proven to improve the yield and sensitivity of Navigational bronchoscopic guided Biopsy of the lung nodules and masses. Out of the various navigational platforms we have, most of them are based on Electromagnetic guidance and some on Shape sensing technology. Some of the platforms have fixed angle catheter while the newer robotic platforms have articulating catheters with much more range of motion. So far we do not have any data directly comparing the diagnostic yield of Electromagnetic navigational bronchoscopy with Robotic shape sensing guided bronchoscopy while using Cone Beam CT and Augmented fluoroscopy with both the platforms. With my study, I want to examine the change in diagnostic yield and sensitivity of fixed angle ENB guided bronchoscopy and articulating robotic shape sensing bronchoscopy both using Cone Beam CT with 3D reconstruction.
详细描述
Navigation bronchoscopy (NB) has been used for more than a decade to access peripheral and central parenchymal lung lesions bronchoscopically. Traditionally standard fluoroscopy using C-arm is used to confirm the location and guide the biopsy instruments under real-time guidance. With availability of Cone Beam CT, fluoroscopic images of much higher quality and resolution can be obtained intra-operatively. It also enables the bronchoscopist to obtain intraoperative CT images and confirm the exact location of the lesion and the Bronchoscopic biopsy catheter or the biopsy instruments.
Recently we have had significant advancements in the technology to guide and operate the instruments used to reach these hard to reach lesions within the lungs. We have different fixed angle electromagnetic guided platforms, articulating robotic electromagnetic guided platforms and articulating robotic shape sensing guided platforms.
At my institution, lung nodules/masses requiring NB has evolved over the years starting from Medtronic Super-Dimension Version 7 Electromagnetic Navigational Bronchoscopy (ENB) system to ION Robotic Bronchoscopy platform (RNB). All the procedures are done under fluroscopic guidance which has also evolved from a regular C-Arm to Philips Cone Beam CT with Augmented Fluoroscopy.
During this evolution we have had Medtronic Super-D ENB with 2D fluoro followed by Medtronic Super-D ENB with CBCT and Augmented fluoroscopy and now have the Ion robotic platform with CBCT and Augmented fluoroscopy with low dose protocol.
All the lesions are confirmed using peripheral/radial Endobronchial Ultrasound (rEBUS). Once the appropriate location is reached, biopsy is obtained using FNA (18G or 21G), Single or Triple needle brush, Transbronchial forceps and Bronchoalveolar lavage is done for cytology or micro studies if needed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with lung nodule
- •Patients with lung mass
- •Patients undergoing navigation bronchoscopy for biopsy of peripheral/central lung lesions.
排除标准
- •Patients less than 18 years of age
- •Patients unable to complete the navigational bronchoscopy procedure.
结局指标
主要结局
Diagnostic Yield
时间窗: 1 year
Percentage of correct underlying diagnosis
Sensitivity for malignancy
时间窗: 1 year
Percentage of malignant lesions accurately diagnosed on biopsy
次要结局
- Intra-Operative time(1 year)
- Procedural Complications(1 year)
- Radiation Exposure(1 year)
研究者
Deepankar Sharma
Medical Director, Lung Institute and Section Chief, Pulmonary & Critical Care
Columbus Regional Health