Randomized Trial of Fluoroscopy Use for Radial Endobronchial Ultrasound-guided Biopsy of Peripheral Lung Lesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Pulmonary Lesions
- Sponsor
- Laval University
- Enrollment
- 133
- Locations
- 1
- Primary Endpoint
- Diagnostic yield
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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
Investigators
Antoine Delage
MD
Laval University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Diagnostic yield
Time Frame: 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
Time Frame: 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 Outcomes
- Lesion localization(Immediate (during the test))
- Procedure duration(During the test)
- Complications(Immediately during the test and up to 4 hours after the test)