- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00861835
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
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.
Study Overview
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Eligible patients included all adults referred for bronchoscopy with anticipated TBNA.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ROSE for TBNA
|
rapid on-site evaluation by cytopathology
|
No Intervention: NR
no on-site cytopathology assessment (NR)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
diagnostic yield
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MMCROSE
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