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NCT00861835 Clinical Trial

Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate (TBNA)

Bronchoscopy Clinical Trial

Official title:
A Randomized Prospective Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate Specimens

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00861835
Other study ID # MMCROSE
Secondary ID
Status Completed
Phase N/A
First received March 12, 2009
Last updated March 12, 2009
Start date November 2004
Est. completion date December 2007

Study information
Verified date March 2009
Source Maine Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date December 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Other:
• ROSE
rapid on-site evaluation by cytopathology

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Maine Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary diagnostic yield No
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