Thin and Ultrathin Bronchoscopy With Transbronchial Needle Aspiration and Radial Probe Endobronchial Ultrasound for Peripheral Pulmonary Lesions
Study Details
Study Description
Brief Summary
A limitation of current approaches to peripheral lesions may be the caliber of bronchoscope used to reach them. As peripheral airways taper further in size, the ability of the bronchoscopist to approximate peripheral lesions diminishes using conventionally sized bronchoscopes of 5 or 4mm in outer diameter. Because of this limitation, the bronchoscopist may be unable to cannulate peripheral airways that lead directly to targeted lesions, thereby significantly compromising the diagnostic yield of the procedure. Ultrathin bronchoscopy utilizing bronchoscopes of 3mm in outer diameter may allow bronchoscopists better access to the lung periphery, thereby allowing access to peripheral airways that may lead directly into targeted lesions, resulting in a concentric anatomical position, where diagnostic yields may be improved.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bronchoscopy Following airway inspection, the radial endobronchial ultrasound probe will be inserted through the working channel of the 4mm bronchoscope and will be advanced into the targeted bronchial segment towards the targeted lesion. Bronchoscopy will be performed using monoplanar fluoroscopic guidance until the peripheral lesion is located and confirmed using radial probe EBUS. a. If a concentric view is obtained, biopsy will proceed using conventional instruments (TBNA) through the 4mm bronchoscope. b. If an eccentric view is obtained, the 4mm bronchoscope will be withdrawn and the 3mm bronchoscope with the radial ultrasound probe will be advanced to the target lesion. Attempts will be made using the 3mm bronchoscope to obtain concentric views and ability to do so will be recorded. Biopsies will be obtained using conventional instruments (TBNA)through the 3mm bronchoscope regardless of the final ultrasound image (concentric or eccentric). |
Device: BF-P190 4 mm thin bronchoscope
EVIS EXERA III Bronchofiberviedoscopes
Olympus
Device: BF-MP190F 3 mm ultrathin bronchoscope
EVIS EXERA III Bronchofiberviedoscopes
Olympus
Device: Radial ultrasound probe (UM S20-17S)
-Olympus
Device: PeriView FLEX 21G Single Use Aspiration Needle
NA-403D-2021
Gyrus ACMI, Inc.
|
Outcome Measures
Primary Outcome Measures
- Overall diagnostic yield (concentric and eccentric lesions) for peripheral pulmonary nodules [Receipt of cytology/histopathology results (approximately 7 days)]
-To detect a 15% improvement in overall diagnostic yield (concentric and eccentric lesions) for peripheral pulmonary nodules utilizing using a combined approach of 4mm thin and 3mm ultrathin bronchoscopes with TBNA and radial EBUS compared to a historic baseline diagnostic yield of 60% established at Washington University School of Medicine (WUSM) when using TBNA and radial EBUS and a 4mm thin bronchoscope.
Secondary Outcome Measures
- Incidence of related adverse events [Up to 4 days following procedure]
-Adverse events related to the bronchoscopy procedure and/or devices used during the procedure (bronchoscope, radial EBUS, PeriView Flex needle).
- Procedure time measured in minutes from oral scope insertion to scope removal upon completion of the bronchoscopy procedure [From start of procedure through end of procedure (day 1)]
- Size of target lesions measured at the greatest diameter in centimeters [From start of procedure through end of procedure (day 1)]
- Diagnostic yield of bronchoscopy utilizing a 3mm bronchoscope for eccentric lesions [Receipt of cytology/histopathology results (approximately 7 days)]
-Will be compared with historical controlled data of cases in which peripheral bronchoscopy was performed for peripheral lesions using radial probe EBUS and a 4mm bronchoscope in which eccentric ultrasound views were obtained
- Ability to successfully convert ultrasound images from eccentric to concentric view by exchanging the 4mm thin bronchoscope for the 3mm ultrathin bronchoscope [From start of procedure through end of procedure (day 1)]
-The ability to convert will be based on the ultrasound image that is obtained using the 3mm bronchoscope (it will either be eccentric or concentric) compared to the eccentric ultrasound image obtained with the 4mm bronchoscope
- Types of deficiencies associated with medical device [From start of procedure through end of procedure (day 1)]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients age 18 and older
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Patients presenting with peripheral pulmonary lesions 1-7cm in greatest diameter on axial CT or PET scan in need of bronchoscopic biopsy for clinical purposes
Exclusion Criteria:
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Patients who are unable to undergo flexible bronchoscopy as determined by the bronchoscopist prior to the procedure
-
Patients unwilling or unable to provide informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
- Olympus
Investigators
- Principal Investigator: Alexander Chen, M.D., Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 202003071