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

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. Identifier: NCT00861835
Recruitment Status : Completed
First Posted : March 13, 2009
Last Update Posted : March 13, 2009
Information provided by:
Maine Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Bronchoscopy Other: ROSE Not Applicable

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Diagnostic
Official Title: A Randomized Prospective Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate Specimens
Study Start Date : November 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : December 2007

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

Primary Outcome Measures :
  1. diagnostic yield

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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.

Responsible Party: Lonny Yarmus, DO, Maine Medical Center Identifier: NCT00861835     History of Changes
Other Study ID Numbers: MMCROSE
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009