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

This study has been completed.
Information provided by:
Maine Medical Center Identifier:
First received: March 12, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

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
Other: ROSE

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: A Randomized Prospective Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate Specimens

Further study details as provided by Maine Medical Center:

Primary Outcome Measures:
  • diagnostic yield

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
Experimental: ROSE for TBNA Other: ROSE
rapid on-site evaluation by cytopathology
No Intervention: NR
no on-site cytopathology assessment (NR)


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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No Contacts or Locations Provided
  More Information

Responsible Party: Lonny Yarmus, DO, Maine Medical Center Identifier: NCT00861835     History of Changes
Other Study ID Numbers: MMCROSE
Study First Received: March 12, 2009
Last Updated: March 12, 2009 processed this record on April 26, 2017