Trials / Completed
CompletedNCT00861835
Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate (TBNA)
A Randomized Prospective Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate Specimens
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- MaineHealth · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | ROSE | rapid on-site evaluation by cytopathology |
Timeline
- Start date
- 2004-11-01
- Primary completion
- 2007-11-01
- Completion
- 2007-12-01
- First posted
- 2009-03-13
- Last updated
- 2009-03-13
Source: ClinicalTrials.gov record NCT00861835. Inclusion in this directory is not an endorsement.