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

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ClinicalTrials.gov Identifier: NCT00915330

Recruitment Status : Completed

First Posted : June 8, 2009

Last Update Posted : February 19, 2010

Sponsor:

Information provided by:

Maggiore Bellaria Hospital, Bologna

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Lung Cancer Sarcoidosis Tuberculosis	Procedure: Rapid on-site cytopathologic evaluation (ROSE) Procedure: TBNA	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	164 participants
Allocation:	Randomized
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Transbronchial Needle Aspiration With and Without Rapid On-site Cytopathologic Evaluation in the Diagnostic Approach to Hilar/Mediastinal Adenopathy: A Randomized Controlled Trial.
Study Start Date :	May 2009
Actual Primary Completion Date :	February 2010
Actual Study Completion Date :	February 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Lung cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: TBNA alone Arm A: TBNA alone.	Procedure: TBNA transbronchial needle aspiration
Experimental: TBNA with ROSE Arm B: TBNA with ROSE.	Procedure: 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. Procedure: TBNA transbronchial needle aspiration

Outcome Measures

Primary Outcome Measures :

Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm [ Time Frame: 6-12 months ]

Secondary Outcome Measures :

Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm [ Time Frame: 6-12 months ]
Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm [ Time Frame: 6-12 months ]
Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm [ Time Frame: 6-12 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00915330

Locations

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Italy
Maggiore Hospital
Bologna, Italy, 40133

Sponsors and Collaborators

Maggiore Bellaria Hospital, Bologna

Investigators

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Principal Investigator:	Marco Patelli, MD	Maggiore Hospital

More Information

Publications of Results:

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.

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

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

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Marco Patelli, Maggiore Bellaria Hospital
ClinicalTrials.gov Identifier:	NCT00915330
Other Study ID Numbers:	01-Trisolini
First Posted:	June 8, 2009 Key Record Dates
Last Update Posted:	February 19, 2010
Last Verified:	February 2010

Keywords provided by Maggiore Bellaria Hospital, Bologna:


Transbronchial needle aspiration Bronchoscopy Rapid on-site cytopathologic evaluation Mediastinal lymphadenopathy Hilar Lymphadenopathy

Additional relevant MeSH terms:

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Tuberculosis Sarcoidosis Lymphadenopathy Mycobacterium Infections Actinomycetales Infections	Gram-Positive Bacterial Infections Bacterial Infections Lymphoproliferative Disorders Lymphatic Diseases

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