First Evaluation of the Next-Generation Endobronchial Ultrasound System in Preclinical Models

Abstract

Background: The next-generation convex probe endobronchial ultrasound (CP-EBUS) was developed to improve the ease of operation and the acquisition of EBUS skills for new trainees. The aim of this study was to evaluate the changes in the prototype next-generation CP-EBUS compared with the current CP-EBUS.

Methods: The prototype next-generation CP-EBUS, with a decreased forward oblique view, more flexible angulation range, smaller ultrasound probe, and sharper needle angle, was compared with the current CP-EBUS. The operability, which was evaluated by using a 5-level Likert-type scale, and safety were evaluated in 2 live pigs, a cadaveric lung, and 10 ex vivo human lungs by 9 bronchoscopists. The time required to access the upper lobe bronchus and the time required to detect prespecified lymph node stations by 7 novice bronchoscopists with both CP-EBUS were compared with assess the operability difference for new trainees.

Results: In all evaluated models, operability (eg, maneuverability, endoscopic visibility, bronchial trees selectivity, insertability to the upper airway) was scored 5 (significantly improved). All trainee bronchoscopists were able to access the upper lobe bronchi and detect each lymph node except 4R significantly faster than with the current CP-EBUS without any airway damage.

Conclusions: The next-generation CP-EBUS has improved operability, which resulted in better access to each lobar bronchus and more prompt detection of mediastinal or hilar lymph nodes. These improvements may allow more precise lymph node staging and diagnosis, as well as improve EBUS procedural skill acquisition, once introduced to clinical practice.