Benign and Malignant Mediastinal and Hilar Lymph Nodes Known or Suspected Malignancy, ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION
Conditions
Keywords
enlarged mediastinal nodes, enlarged hilar lymph nodes
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.
Interventions
PROCEDUREROSE
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.
DEVICE22 gauge Vizishot needles
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time lapse | during procedure, approximately 45 minutes | The primary endpoint is the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of sampled lymph nodes | approximately 45 minutes | Samples taken during procedure |
| Average number of needle aspirations per lymph node sampled | approximately 45 minutes | Determined by tumor |
| Overall diagnostic yield | approximately 45 minutes | — |
| Procedural time of the cytopathologist | approximately 30 minutes | — |
Countries
United States
Outcome results
None listed