Randomized trial comparing the fork-tip and the side-fenestrated needles for EUS-guided fine-needle biopsy of solid pancreatic lesions.

Abstract Background and aims The aim of this study was to compare the performance of EUS-guided fine-needle biopsy using fork-tip (SharkCore, Medtronic, USA) or side-fenestrated (ProCore, Cook Medical, Limerick, Ireland) needles in patients with solid pancreatic lesions. Methods This is a randomized controlled study conducted in a single academic center, including patients who underwent sampling with the fork-tip or the side-fenestrated 22-gauge or 25-gauge needles. Three passes were performed, which were each independently evaluated by a blinded pathologist and by endosonographers for macroscopic on-site evaluation (MOSE). The primary outcome was histological yield, whereas secondary aims were safety, diagnostic yield, sample quality, number of needle passes required to establish a diagnosis, and reliability of MOSE. Results One hundred ninety-two patients were enrolled. Both 22-gauge and 25-gauge fork-tip needles retrieved significantly higher rates of histological samples compared with side-fenestrated (p Conclusions Both needles showed equivalent safety and diagnostic accuracy. However, fork-tip needles provided higher rate of extremely good quality histological samples and required fewer needle passes to reach a diagnosis. MOSE is a highly reliable tool when fork-tip needles are used as compared with side-fenestrated needles. ClinicalTrial.gov number NCT03622229