Peripheral Pulmonary Lesions
Conditions
Keywords
Radial endobronchial ultrasound, Peripheral lung lesion, Fluoroscopy, Lung cancer
Brief summary
The purpose of this study is to determine whether the use of fluoroscopy improves the diagnostic yield of peripheral pulmonary lesions' biopsy guided by radial endobronchial ultrasound (with the use of a guide sheath).
Detailed description
See above
Interventions
PROCEDUREFluoroscopy
PROCEDURERadial EBUS-guided biopsy
Sponsors
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive patients referred for the bronchoscopic diagnosis of peripheral pulmonary lesions at the Institut Universitaire de Cardiologie et de Pneumologie de Québec(not visible endobronchially) * Adults over the age of 18
Exclusion criteria
* Therapeutic anticoagulation * Antiplatelet therapy other than aspirin * Known hemorrhagic diathesis * Acute respiratory failure * Pregnancy * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield | Upon production of pathology results, usually within 2 weeks after the test | Diagnostic yield of radial endobronchial ultrasound-guided biopsy for peripheral lung lesions defined as the proportion of patients in whom a specific diagnosis is established by radial endobronchial ultrasound-guided biopsy. The analysis will be stratified by lesion size, location, the presence of the bronchus sign, type of echographic image obtained (central/peripheral), physician involved, resident involvement. |
| Sensitivity and specificity | Upon completion of ancillary or confirmatory tests, usually within 2 months after the test | Sensitivity and specificity are determined separately for malignancy and benign etiologies. Case records will be reviewed for patients with non-diagnostic specimen and results from other diagnostic procedures (TTNA, surgical biopsy) will be reviewed. For patients without further diagnostic tests, stability or progression of the lesion over time will be used for etiology attribution. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion localization | Immediate (during the test) | Proportion of patients in whom the peripheral pulmonary lesion was localized using the radial endobronchial ultrasound. |
| Procedure duration | During the test | Total duration of the bronchoscopic test. |
| Complications | Immediately during the test and up to 4 hours after the test | occurrence of pneumothorax (and its management), bleeding more than 50ml, sustained desaturation below 90%, cardiac dysrhythmias, or any other adverse events occuring during or after the procedure. |
Countries
Canada
Outcome results
None listed