EBUS-TBNA versus EUS-B-FNA for the evaluation of undiagnosed mediastinal lymphadenopathy: The TEAM randomized controlled trial.

Background: Endobronchial Ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a standard of care modality for the evaluation of mediastinal lymphadenopathy. Transesophageal Bronchoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-B-FNA), wherein one introduces the EBUS bronchoscope through the esophageal route, is also a safe and efficacious diagnostic modality for sampling the mediastinal lymph nodes. The objective of this study was to compare the diagnostic yield and patient comfort with these two available approaches.

Methods: We randomized subjects with predominant subcarinal or lower left paratracheal mediastinal lymph node enlargement to either EBUS-TBNA or EUS-B-FNA (50 to each group). Co-Primary objectives were the comparison of adequate and diagnostic aspirates between groups. Key secondary objectives were a comparison of Operator rated cough and Operator rated procedural comfort on Visual Analog scale (VAS), procedure duration and complications between the groups.

Results: Baseline characteristics were comparable between the groups. The proportion of adequate (EBUS-TBNA 46/50; 92% and EUS-B-FNA 48/50;96%, P = 0.4) and diagnostic aspirates (EBUS-TBNA 38/50; 76% and EUS-B-FNA 36/50;74%, P = 0.4) were similar between the two groups. Operator rated cough was significantly less, and Operator rated patient comfort significantly higher with the EUS-B-FNA approach. Procedure duration was significantly shorter with EUS-B-FNA [18.1(14.4) minutes versus 16.4 (49.6) minutes, P < 0.001]. Minor complications occurred in one patient in the EBUS-TBNA group and none in the EUS-B-FNA group.

Conclusions: During the endosonographic evaluation for undiagnosed mediastinal lymphadenopathy located at predominantly the subcarinal or lower left paratracheal stations, EUS-B-FNA as compared with EBUS-TBNA provides greater patient comfort with a similar diagnostic yield.