Rapid On-site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy

NCT ID: NCT00915330

Last Updated: 2010-02-19

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

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to determine whether rapid on-site cytopathologic evaluation (ROSE) can increase the diagnostic yield of transbronchial needle aspiration (TBNA) in the diagnosis of hilar and mediastinal lymphadenopathy.

Detailed Description

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Conditions

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Lung Cancer Sarcoidosis Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TBNA alone

Arm A: TBNA alone.

Group Type ACTIVE_COMPARATOR

TBNA

Intervention Type PROCEDURE

transbronchial needle aspiration

TBNA with ROSE

Arm B: TBNA with ROSE.

Group Type EXPERIMENTAL

Rapid on-site cytopathologic evaluation (ROSE)

Intervention Type PROCEDURE

ROSE: examination in the endoscopy suite, by a pathologist, during the bronchoscopic procedure, of samples obtained with transbronchial needle aspiration.

TBNA

Intervention Type PROCEDURE

transbronchial needle aspiration

Interventions

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Rapid on-site cytopathologic evaluation (ROSE)

ROSE: examination in the endoscopy suite, by a pathologist, during the bronchoscopic procedure, of samples obtained with transbronchial needle aspiration.

Intervention Type PROCEDURE

TBNA

transbronchial needle aspiration

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 years old and older
* Hilar and/or mediastinal lymphadenopathy (\> 1 cm on the short axis, as assessed by contrast-enhanced CT scan (computed tomography))

Exclusion Criteria

* Uncontrolled coagulopathy
* Refusal to sign informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maggiore Bellaria Hospital, Bologna

OTHER

Sponsor Role lead

Responsible Party

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Maggiore Bellaria Hospital

Principal Investigators

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Marco Patelli, MD

Role: PRINCIPAL_INVESTIGATOR

Maggiore Hospital

Locations

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Maggiore Hospital

Bologna, , Italy

Site Status

Countries

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Italy

References

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Diacon AH, Schuurmans MM, Theron J, Louw M, Wright CA, Brundyn K, Bolliger CT. Utility of rapid on-site evaluation of transbronchial needle aspirates. Respiration. 2005 Mar-Apr;72(2):182-8. doi: 10.1159/000084050.

Reference Type RESULT
PMID: 15824529 (View on PubMed)

Davenport RD. Rapid on-site evaluation of transbronchial aspirates. Chest. 1990 Jul;98(1):59-61. doi: 10.1378/chest.98.1.59.

Reference Type RESULT
PMID: 2361413 (View on PubMed)

Baram D, Garcia RB, Richman PS. Impact of rapid on-site cytologic evaluation during transbronchial needle aspiration. Chest. 2005 Aug;128(2):869-75. doi: 10.1378/chest.128.2.869.

Reference Type RESULT
PMID: 16100180 (View on PubMed)

Diette GB, White P Jr, Terry P, Jenckes M, Rosenthal D, Rubin HR. Utility of on-site cytopathology assessment for bronchoscopic evaluation of lung masses and adenopathy. Chest. 2000 Apr;117(4):1186-90. doi: 10.1378/chest.117.4.1186.

Reference Type RESULT
PMID: 10767258 (View on PubMed)

Trisolini R, Cancellieri A, Tinelli C, Paioli D, Scudeller L, Casadei GP, Forti Parri S, Livi V, Bondi A, Boaron M, Patelli M. Rapid on-site evaluation of transbronchial aspirates in the diagnosis of hilar and mediastinal adenopathy: a randomized trial. Chest. 2011 Feb;139(2):395-401. doi: 10.1378/chest.10-1521. Epub 2010 Oct 28.

Reference Type DERIVED
PMID: 21030491 (View on PubMed)

Other Identifiers

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01-Trisolini

Identifier Type: -

Identifier Source: org_study_id

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