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

MaineHealth

Overview

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.

Study Type

INTERVENTIONAL

Purpose

DIAGNOSTIC

Conditions

Bronchoscopy

Interventions

ROSEOTHER

rapid on-site evaluation by cytopathology

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

diagnostic yield

Data from ClinicalTrials.gov

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