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临床试验/NCT04194333
NCT04194333已完成不适用

Comparing Diagnostic Yield of Electromagnetic Navigational Bronchoscopy Guided With Real Time Cone Beam Computer Tomography With Standard Fluoroscopy Guidance for Peripheral and Central Lung Lesions

Columbus Regional Health1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2017年8月1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
180
试验地点
1
主要终点
Diagnostic Yield

研究概览

简要总结

Electromagnetic navigation bronchoscopy (ENB) is used to access peripheral and central parenchymal lung lesions via endobronchial and transbronchial approach. Traditionally ENB 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 is thought to improve the yield and sensitivity of ENB guided Biopsy of the lung nodules and masses but has not been proven in a prospective trial. With my study, I want to examine the effect of Cone Beam CT with 3D reconstruction on the diagnostic yield and sensitivity of Electromagnetic Navigational Bronchoscopic biopsy of the lung lesions.

详细描述

Electromagnetic navigation bronchoscopy 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.

At my institution, lung nodules/masses requiring ENB have been approached using Medtronic Super-Dimension Version 7 Electromagnetic Navigational Bronchoscopy system. All the procedures are done under fluroscopic guidance using a regular C-Arm. All the lesions are confirmed using peripheral Endobronchial Ultrasound (EBUS). Once the appropriate location is reached, biopsy is obtained using FNA (18G or 21G), Single or Triple needle brush, Transbronchial forceps and Bronchoalveolar lavage.

A pathologist is present on site for all the cases to review the slides and assist in diagnosis. All the cases are done under general anesthesia through endotracheal tube.

Also, all the ENB procedures have been performed by one Interventional Pulmonologist since August 2017.

For the interventional arm, all the aspects will remain the same except that the cases are done in Hybrid OR instead of Endoscopy. All the patients are completely paralyzed intra-operatively. Also, instead of a standard C-Arm providing 2D fluoroscopic guidance, a Philips Azurion 7 C20 FlexMove system with Emboguide, 3D Segmentaion and Overlay tools is being used. This enables the bronchoscopist to obtain a CT scan of the chest and also segment out the lesion(s) of interest and to overlap the 3-D image of the lesion on live fluoroscopy in all 3 dimensions.

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

入选标准

  • Patients with lung nodule
  • Patients with lung mass
  • Patients undergoing undergoing electromagnetic navigation bronchoscopy for biopsy.

排除标准

  • Patients less than 18 years of age
  • Patients unable to complete the electromagnetic navigational bronchoscopy procedure.

结局指标

主要结局

Diagnostic Yield

时间窗: 1 year Follow up. Prelim results to be reviewed at 3 months

Percentage of correct underlying diagnosis

Sensitivity for malignancy

时间窗: 1 year Follow up. Prelim results to be reviewed at 3 months

Percentage of malignant lesions accurately diagnosed on biopsy

次要结局

  • Radiation Exposure(1 year Follow up. Prelim results to be reviewed at 3 months)
  • Procedure Time(1 year Follow up. Prelim results to be reviewed at 3 months)
  • Procedural Complications(1 year Follow up. Prelim results to be reviewed at 3 months)

研究者

发起方
Columbus Regional Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Deepankar Sharma

Medical Director, Lung Institute and Section Chief, Pulmonary & Critical Care

Columbus Regional Health

研究点 (1)

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