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Completed

NCT Number: NCT00861835

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

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.

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Key information

Conditions

Bronchoscopy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ROSE

Other

rapid on-site evaluation by cytopathology

Primary outcomes

  1. diagnostic yield

Sponsors and collaborators

Lead sponsor

MaineHealth

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Mar 13, 2009
Registry last updated
Mar 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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