Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05358041 |
Other study ID # |
007 |
Secondary ID |
|
Status |
Enrolling by invitation |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 3, 2021 |
Est. completion date |
November 3, 2022 |
Study information
Verified date |
April 2022 |
Source |
Columbus Regional Health |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
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 NB 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 procedure
will utilize Ion Robotic bronchoscopy platform and pre-operatively every patient will undergo
incentive spirometry, dual short acting bronchodilator treatment and will be maintained at
relatively higher PEEP and Lower FiO2 than before.
The diagnostic yield will be compared to the patients who underwent procedure using Super-D
Electromagnetic platform with CBCT and Augmented Fluoroscopy.
All cases are still done in Hybrid ORand all the patients are completely paralyzed
intra-operatively. Also, all procedures in both arms will use a Philips Azurion 7 C20
FlexMove system with Emboguide, 3D Segmentaion and Overlay tools. 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 and RNB procedures, at least 1 full Xpert CT is obtained, mostly after
completing the airway registration and advancing the guided catheter to the lesion of
interest. Once the extended working channel and the locatable guide or The robotic
articulating catheter is advanced to the lesion using ENB/Shape sensing guidance, the
catheter is held at that position and 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/robotic
catheter 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 biopsy instruments, use of peripheral
Endobronchial Ultrasound and availability of on-site pathologist. The biopsy instruments
include transbronchial needle for FNA, Single or triple needle brush and transbronchial
forceps. Bronchoalveolar lavage is also obtained at the end via working channel.
All the patients undergoing biopsy of the peripheral/central lung lesions using ENB/RNB 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 difference in diagnostic yield and sensitivity of electromagnetic
navigational bronchoscopy with fixed angle catheter vs robotic shape sensing bronchoscopy
with articulating catheter while using Cone Beam CT with segmentation, 3-D overlay and CT
augmented fluoroscopy for diagnosis of peripheral and central lung lesions including lung
nodules and masses which could not be directly accessed using just white light bronchoscope.