Rapid On-site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy
NCT ID: NCT00915330
Last Updated: 2010-02-19
Study Results
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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COMPLETED
NA
164 participants
INTERVENTIONAL
2009-05-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
DIAGNOSTIC
NONE
Study Groups
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TBNA alone
Arm A: TBNA alone.
TBNA
transbronchial needle aspiration
TBNA with ROSE
Arm B: TBNA with ROSE.
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.
TBNA
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.
TBNA
transbronchial needle aspiration
Eligibility Criteria
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Inclusion Criteria
* Hilar and/or mediastinal lymphadenopathy (\> 1 cm on the short axis, as assessed by contrast-enhanced CT scan (computed tomography))
Exclusion Criteria
* Refusal to sign informed consent
18 Years
90 Years
ALL
No
Sponsors
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Maggiore Bellaria Hospital, Bologna
OTHER
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
Countries
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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.
Davenport RD. Rapid on-site evaluation of transbronchial aspirates. Chest. 1990 Jul;98(1):59-61. doi: 10.1378/chest.98.1.59.
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.
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.
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.
Other Identifiers
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01-Trisolini
Identifier Type: -
Identifier Source: org_study_id
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