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similar study data published
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The objective of this study is comparing the attributable procedural time of Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) when sampling mediastinal and hilar lymph nodes with or without Rapid On-Site Evaluation (ROSE). The primary outcome will be the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. Secondary outcomes will include total number of sampled lymph nodes, average number of needle aspirations per lymph node sampled, overall diagnostic yield, and procedural time of the cytopathologist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROSE | Other | In the case of ROSE, sampling frequency will occur similarly, but no additional samples will be taken in the case of provision of a preliminary diagnosis. |
|
| NO ROSE | Other | In the case of no ROSE, sampling frequency will be predetermined at 4 needle aspirations per site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ROSE | Procedure | The procedure will proceed with conventional EBUS-TBNA sampling of the target lesion with 22 gauge Vizishot needles. Each subject will be randomized to either ROSE by cytopathologist or no ROSE. |
| Measure | Description | Time Frame |
|---|---|---|
| Time lapse | The primary endpoint is the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. | during procedure, approximately 45 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of sampled lymph nodes | Samples taken during procedure | approximately 45 minutes |
| Average number of needle aspirations per lymph node sampled | Determined by tumor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Momen Wahidi, MD, MBA | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15249452 | Background | Yasufuku K, Chiyo M, Sekine Y, Chhajed PN, Shibuya K, Iizasa T, Fujisawa T. Real-time endobronchial ultrasound-guided transbronchial needle aspiration of mediastinal and hilar lymph nodes. Chest. 2004 Jul;126(1):122-8. doi: 10.1378/chest.126.1.122. | |
| 1076725 | Background | Mejia CP. [Surgery and orthodontics in the treatment of unerupted maxillary cuspids]. Rev Fed Odontol Colomb. 1976 Jan-Jun;24(116-117):47-52. No abstract available. Spanish. |
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| 22 gauge Vizishot needles | Device |
|
| approximately 45 minutes |
| Overall diagnostic yield | approximately 45 minutes |
| Procedural time of the cytopathologist | approximately 30 minutes |
| 22145008 | Background | Griffin AC, Schwartz LE, Baloch ZW. Utility of on-site evaluation of endobronchial ultrasound-guided transbronchial needle aspiration specimens. Cytojournal. 2011;8:20. doi: 10.4103/1742-6413.90081. Epub 2011 Nov 21. |
| 11668466 | Background | Layfield LJ, Bentz JS, Gopez EV. Immediate on-site interpretation of fine-needle aspiration smears: a cost and compensation analysis. Cancer. 2001 Oct 25;93(5):319-22. doi: 10.1002/cncr.9046. |