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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TBNA alone | Active Comparator | Arm A: TBNA alone. |
|
| TBNA with ROSE | Experimental | Arm B: TBNA with ROSE. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid on-site cytopathologic evaluation (ROSE) | Procedure | ROSE: examination in the endoscopy suite, by a pathologist, during the bronchoscopic procedure, of samples obtained with transbronchial needle aspiration. |
| Measure | Description | Time Frame |
|---|---|---|
| Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm | 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm | 6-12 months | |
| Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm | 6-12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Patelli, MD | Maggiore Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maggiore Hospital | Bologna | 40133 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15824529 | Result | 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. | |
| 2361413 | Result | Davenport RD. Rapid on-site evaluation of transbronchial aspirates. Chest. 1990 Jul;98(1):59-61. doi: 10.1378/chest.98.1.59. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D012507 | Sarcoidosis |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| TBNA | Procedure | transbronchial needle aspiration |
|
| Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm | 6-12 months |
| 16100180 | Result | 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. |
| 10767258 | Result | 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. |
| 21030491 | Derived | 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |