Benign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy Clinical Trial
— ROSEOfficial title:
Procedural Outcomes in Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) With and Without Rapid On-Site Evaluation (ROSE) by Cytopathologist
| Verified date | January 2015 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 37 |
| Est. completion date | November 2014 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Subject provides informed consent 2. Subject is >18 years of age 3. Subject is scheduled to undergo flexible bronchoscopy with EBUS-TBNA of suspected enlarged mediastinal or hilar lymph nodes as part of their standard medical care 4. A negative pregnancy test in women of child-bearing potential 5. Subject is mentally capable of following study directions Exclusion Criteria: 1. Study subject has any disease or condition that interferes with safe completion of initial or follow-up assessments 2. Concurrent participation in another study involving investigational drugs or investigational medical devices 3. Inability to read and understand the necessary study documents |
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke University Medical Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University |
United States,
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. — View Citation
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. — View Citation
Mejia CP. [Surgery and orthodontics in the treatment of unerupted maxillary cuspids]. Rev Fed Odontol Colomb. 1976 Jan-Jun;24(116-117):47-52. Spanish. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time lapse | The primary endpoint is the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. | during procedure, approximately 45 minutes | |
| Secondary | Total number of sampled lymph nodes | Samples taken during procedure | approximately 45 minutes | |
| Secondary | Average number of needle aspirations per lymph node sampled | Determined by tumor | approximately 45 minutes | |
| Secondary | Overall diagnostic yield | approximately 45 minutes | ||
| Secondary | Procedural time of the cytopathologist | approximately 30 minutes |