Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04194333 |
| Other study ID # |
001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2017 |
| Est. completion date |
November 2, 2021 |
Study information
| Verified date |
July 2022 |
| Source |
Columbus Regional Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
During the ENB procedures, at least 1 full Xpert CT is going to be obtained, mostly after
completing the airway registration and ENB guided approach the lesion. Once the extended
working channel and the locatable guide is advanced to the lesion using ENB guidance, the
catheter is locked and scope held in place. The patient is maintained in inspiratory breath
hold and Cone Beam Ct is used to obtain the Xpert CT that shows the lesion and surrounding
lungs, chest and mediastinal structures in the surrounding area of the chest.
This is then used to analyze the location of the lesion and the lesion of the extended
working channel, locatable guide and the biopsy instruments in relation to the lesion. The
lesion is then segmented and EmboGuide+Overlay feature is used to project a 3D view of the
lesion on the live fluoroscopic images in all three axis. This also allows the bronchoscopist
to obtain Anterior-posterior, Lateral and oblique views at various angles while maintaining
the 3D overlap.
Additional CT scans might be obtained intra-operatively if needed to guide the biopsy
catheter appropriately towards the lesion. Due to the live nature of the Cone Beam CT, it is
much more capable of providing accurate guidance regarding the location of the lesion and the
biopsy instruments. hence, in case of any discrepancy, information provided by Cone Beam CT
is considered more reliable and used with higher confidence.
Rest of the steps involved in procedure are similar between the control and the
interventional arm including the surgeon, type of bronchoscopes, type of electromagnetic
navigational system, use of peripheral Endobronchial Ultrasound and availability of on-site
pathologist. The biopsy instruments used are also the same including transbronchial needle
for FNA, Single or triple needle brush and transbronchial forceps. Bronchoalveolar lavage is
also obtained at the end via extended working channel.
All the patients undergoing biopsy of the peripheral/central lung lesions using ENB also
undergo Convex EBUS guided mediastinal surveillance and EBUS-TBFNA of any Lymph Node that
appears to be greater than 5 mm on EBUS exam.
My study aims to study the effect of using Cone Beam CT with segmentation, 3-D overlay and CT
augmented fluoroscopy on sensitivity and diagnostic yield of electromagnetic navigation
bronchoscopy for diagnosis of peripheral and central lung lesions including lung nodules and
masses which could not be directly accessed using just white light bronchoscope.
