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Sponsored by: |
Maine Medical Center |
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Information provided by: | Maine Medical Center |
ClinicalTrials.gov Identifier: | NCT00861835 |
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.
Condition | Intervention |
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Bronchoscopy |
Other: ROSE |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | A Randomized Prospective Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate Specimens |
Study Start Date: | November 2004 |
Study Completion Date: | December 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ROSE for TBNA: Experimental |
Other: ROSE
rapid on-site evaluation by cytopathology
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NR: No Intervention
no on-site cytopathology assessment (NR)
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Maine Medical Center ( Lonny Yarmus, DO ) |
Study ID Numbers: | MMCROSE |
Study First Received: | March 12, 2009 |
Last Updated: | March 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00861835 History of Changes |
Health Authority: | United States: Institutional Review Board |