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

NCT ID: NCT00861835

Last Updated: 2009-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bronchoscopy

Study Design

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Primary Study Purpose

DIAGNOSTIC

Study Groups

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ROSE for TBNA

Group Type EXPERIMENTAL

ROSE

Intervention Type OTHER

rapid on-site evaluation by cytopathology

NR

no on-site cytopathology assessment (NR)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ROSE

rapid on-site evaluation by cytopathology

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MaineHealth

OTHER

Sponsor Role lead

Responsible Party

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Maine Medical Center

Other Identifiers

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MMCROSE

Identifier Type: -

Identifier Source: org_study_id

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