The Feasibility and Histological Diagnostic Accuracy of Novel Menghini Needle (EUS Sonopsy CY™) for Endoscopic Ultrasound-Guided Fine-Needle Aspiration Biopsy of Solid Pancreatic Masses: A Prospective Crossover Study Comparing Standard Biopsy Needles

Background and Objectives. Recently, a 21G Menghini-type needle for EUS-guided fine-needle aspiration biopsy (EUS-FNAB) has been developed. The stylet of the EUS Sonopsy CY™ remains inside the needle during aspiration. Therefore, it is expected to obtain higher-quality histological core specimens without crushing the material or blood contamination. The aim of this study is to evaluate the feasibility and diagnostic accuracy of EUS-FNAB of solid pancreatic masses with this new biopsy needle. Methods. A total of 30 patients with solid pancreatic masses who underwent EUS-FNAB with two different types of needles, EUS Sonopsy™ and ProCore™, were included in a prospective, randomized, controlled, crossover study. All the pancreatic masses were punctured with the two needles and were randomized regarding the order of the needle to be used. The primary outcome was to compare the diagnostic accuracy and the rates of tissue acquisition of the two needles. Results. The tissue acquisition rate was not significantly different between the EUS Sonopsy CY™ needle and the ProCore™ needle (78.6% vs. 82.1%, P=1.00). The histological diagnostic accuracy was also similar between the two needles (73% vs. 80%, P=.63). There was also no difference regarding the accuracy of cytology alone and the combination of both histological and cytological assessments between the EUS Sonopsy CY™ needle and the ProCore™ needle (90% vs. 87%, P=1.00 and 90% vs. 90%, P=1.00, respectively). Conclusions. EUS Sonopsy CY™ is a reliable device for EUS-FNAB of solid pancreatic masses.