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

NCT00861835 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2009-03-13

No results posted yet for this study

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.

Conditions

  • Bronchoscopy

Interventions

OTHER

ROSE

rapid on-site evaluation by cytopathology

Sponsors & Collaborators

  • MaineHealth

    lead OTHER

Study Design

Purpose
DIAGNOSTIC

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2007-11-30
Completion
2007-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00861835 on ClinicalTrials.gov