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

MaineHealth

Status: Completed

Conditions: Bronchoscopy

Treatments: Other: ROSE

Study type: Interventional

Funder types: Other

Identifiers

NCT00861835

MMCROSE

Details and patient eligibility

About

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.

Sex: All

Volunteers: No 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.

Trial design

0 participants in 2 patient groups

ROSE for TBNA

Experimental group

Treatment:

Other: ROSE

NR

No Intervention group

Description:

no on-site cytopathology assessment (NR)