We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00861835
Recruitment Status : Completed
First Posted : March 13, 2009
Last Update Posted : March 13, 2009
Sponsor:
Information provided by:

Study Description
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
Bronchoscopy Other: ROSE

Study Design

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
Primary Completion Date : November 2007
Study Completion Date : December 2007
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. diagnostic yield

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
More Information

Responsible Party: Lonny Yarmus, DO, Maine Medical Center
ClinicalTrials.gov 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