Diagnostic accuracy of endobronchial ultrasound needle aspiration with and without suction: preliminary results of a single-center randomized controlled trial

F. Gonnelli*^a (Dr), L. Zuccatosta^a (Dr), S. Gasparini^b (Prof)

^a Pulmonary Diseases Unit, Azienda Ospedali Riuniti, Ancona, Italy, Ancona, ITALY ; ^b Polytechnic University of Marche Region, Ancona, Italy, Ancona, ITALY

* francygonnelli@gmail.com

Introduction: The role of ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for the diagnosis of hilar/mediastinal lymphadenopaties is well-established. However, different aspiration techniques are available and it is not clear if there is a significant difference between suction vs no-suction aspiration. Of great interest is the role of different aspiration techniques in EBUS-TBNA in determining the diagnostic accuracy for histopathological evaluation, including molecular biology and PD-L1 amplification assessment in lung cancer diagnosis.

In this context, no comparative studies have been performed; moreover, considering only suction techniques, data exploring the difference between ex-vacuum aspiration and manual aspiration are still lacking.

Methods: Eligible patients were randomized 1:1:1 to either the no-suction aspiration (NS) or ex-vacuum aspiration with EBUS-TBNA dedicated syringe (EV) or manual applied aspiration (MA). The primary endpoint was to test the non-inferiority of NS over the other techniques in terms of diagnostic yield. The secondary endpoint was to assess the adequacy for molecular study in lung cancer.

Results: A total of 120 patients were randomized to either NS (n = 47) or EV (n = 37) or MA (n = 36). The diagnostic yield of the techniques was not statistically different (NS: 95%, EV: 97%, MA: 94% p > 0.05). The sample resulted suitable for molecular assessment in 93% of NS group, in 82% of EV group and 96% of MA group (p > 0.05).

Conclusions: All the available aspiration techniques resulted to be excellent as diagnostic tool of hilar/mediastinal lymphadenopaties, all providing a high diagnostic yield, obtaining histological samples of high quality, even suitable for pathological molecular assessment in lung cancer (i.e. PD-L1 expression). However, these preliminary data suggest that EV provides a lower diagnostic accuracy for molecular analysis, result that needs to be confirmed at the end of the trial reaching an adequate size sample.

Disclosure of funding source(s): none