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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
37
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.
Duke University Medical Center
Durham, North Carolina, United States
Time lapse
The primary endpoint is the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal.
Time frame: during procedure, approximately 45 minutes
Total number of sampled lymph nodes
Samples taken during procedure
Time frame: approximately 45 minutes
Average number of needle aspirations per lymph node sampled
Determined by tumor
Time frame: approximately 45 minutes
Overall diagnostic yield
Time frame: approximately 45 minutes
Procedural time of the cytopathologist
Time frame: approximately 30 minutes
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