LAUSR

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<0.013). Safety and diagnostic accuracy were comparable in the 2 arms, whereas sample quality (tissue integrity and blood contamination) was significantly better in the fork-tip group (p<0.0001). Median number of diagnostic passes was lower using fork-tip needles (p=0.054). The agreement between MOSE and pathological evaluation was almost perfect in the fork-tip group and fair in the side-fenestrated group. 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.