Clinical trial NCT02028052: Procedural Outcomes in Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) With and Without Rapid On-Site Evaluation (ROSE)
Official title: Procedural Outcomes in Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) With and Without Rapid On-Site Evaluation (ROSE) by Cytopathologist
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION
Benign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy
Keywords: enlarged mediastinal nodes
enlarged hilar lymph nodes
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time lapse
timeFrame: during procedure, approximately 45 minutes
Secondary outcomes:
measure: Total number of sampled lymph nodes
timeFrame: approximately 45 minutes
measure: Average number of needle aspirations per lymph node sampled
timeFrame: approximately 45 minutes
measure: Overall diagnostic yield
timeFrame: approximately 45 minutes
measure: Procedural time of the cytopathologist
timeFrame: approximately 30 minutes
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Momen Wahidi, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1378/chest.126.1.122.
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. No abstract available. Spanish.
citation: 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.
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. doi: 10.1002/cncr.9046.