Peripheral Lung Lesions
Conditions
Brief summary
Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. One significant barrier for the bronchoscopic biopsy of peripheral lesions is the ability to reliably locate peripheral lesions in an efficient manner. The majority of the published literature regarding peripheral lesion biopsy has used diagnostic yield as the primary endpoint. Based on this data, it is unclear if non-diagnostic procedures are due to the inability to locate peripheral lesions, or due to the inability to successfully biopsy lesions once located using currently available instruments. This study will evaluate the bronchoscopists' ability to locate peripheral pulmonary lesions by using a conventional chest computed tomography (CT) scan as a reference and a virtual bronchoscopic navigational system, if needed, for the localization of peripheral pulmonary lesions.
Interventions
PROCEDUREConventional bronchoscopy
-Standard of care
DEVICEVIDA Pulmonary Workstation 2
-Virtual bronchoscopic navigation system
PROCEDUREBiopsy
-Standard of care
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with peripheral lung lesions 1-5cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient. * Are at least 18 years old * Are able to provide informed consent * Have CT scans within 30 days suitable for use with the virtual bronchoscopic system
Exclusion criteria
* Patients who refuse to participate * Are less than 18 years of age * Are pregnant * Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist * Are unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Localization of peripheral pulmonary lesions as confirmed using radial probe endobronchial ultrasound | At the time of bronchoscopy (day 1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of lesion localization using a conventional chest CT as a reference only | At the time of bronchoscopy (day 1) | — |
| Rate of lesion localization using virtual bronchoscopic navigation if needed (failed lesion localization using conventional chest CT only) | At the time of bronchoscopy (day 1) | — |
| Time to localization of peripheral pulmonary lesions | At the time of bronchoscopy (day 1) | — |
| Diagnostic yield of procedures | At the time of bronchoscopy (day 1) | -Diagnostic yield based on final cytology and/or histopathology will be determined from the results of the bronchoscopy. A biopsy that results in a specific diagnosis, either malignant or benign, that adequately explains the clinical scenario as determined by the treating physician, will be considered truly positive. |
Outcome results
None listed