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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00861835
First Posted: March 13, 2009
Last Update Posted: March 13, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maine Medical Center
  Purpose

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
Bronchoscopy 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)

  Eligibility

Information from the National Library of Medicine

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

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Lonny Yarmus, DO, Maine Medical Center
ClinicalTrials.gov Identifier: NCT00861835     History of Changes
Other Study ID Numbers: MMCROSE
First Submitted: March 12, 2009
First Posted: March 13, 2009
Last Update Posted: March 13, 2009
Last Verified: March 2009