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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00861835

Enrollment

Unknown

Registered

2009-03-13

Start date

2004-11-30

Completion date

2007-12-31

Last updated

2009-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchoscopy

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.

Interventions

OTHERROSE

rapid on-site evaluation by cytopathology

Study design

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
diagnostic yield	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026