Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate (TBNA)
Not Applicable
Completed
- Conditions
- Bronchoscopy
- Interventions
- Other: ROSE
- Registration Number
- NCT00861835
- Lead Sponsor
- MaineHealth
- Brief Summary
Purpose: Previous studies suggested an increased diagnostic yield for bronchoscopic (FB) transbronchial needle aspirate (TBNA) specimens from mediastinal lymph nodes when using rapid on-site evaluation by cytopathology (ROSE) but were limited by lack of randomization. The investigators performed the first randomized-prospective trial comparing ROSE(R) to no on-site cytopathology assessment (NR).
Methods: All patients referred were eligible. 78 patients were randomized to R or NR groups. For R procedures, further specimens were deferred until results were available from the on-site cytopathologist. Diagnoses made by all procedures were recorded. The primary end-points were specimen adequacy and diagnostic yield.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Eligible patients included all adults referred for bronchoscopy with anticipated TBNA.
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Exclusion Criteria
- Patients were to be excluded only if the attending physician felt ROSE must be used for diagnosis or if the patient refused consent.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ROSE for TBNA ROSE -
- Primary Outcome Measures
Name Time Method diagnostic yield
- Secondary Outcome Measures
Name Time Method