Feasibility of a 20-gauge ProCore needle in EUS-guided subepithelial tumor sampling: a prospective multicenter study

BACKGROUND: Endoscopic ultrasonography-guided fine-needle biopsy (EUS-FNB) may facilitate tissue acquisition for a definitive diagnosis of gastrointestinal subepithelial tumors (SETs). This study aimed to determine the diagnostic yield of EUS-FNB using a novel 20-gauge ProCore needle with a coiled sheath in tissue sampling of gastrointestinal SETs. METHODS: Between July 2016 and February 2017, 39 patients with gastrointestinal SETs were prospectively recruited from six university hospitals in Korea. Hypoechoic SETs ≥2 cm in size and originating from the submucosal and/or muscularis propria layer under EUS were eligible. This study was registered on ClinicalTrials.gov (NCT02884154). RESULTS: A total of 36 patients were included in the final analyses. EUS-FNB was diagnostic in 88.9% of SETs. Tissue adequacy was judged as optimal in 97.2% of FNB specimens according to on-site visual evaluation by endosonographers, and in 88.9% of specimens according to pathologists. A macroscopically optimal core sample was obtained with two needle passes in 94.4% of cases. Technical failure rate was encountered in two cases (5.6%) after two needle passes. There were two cases (5.6%) of bleeding, which was managed endoscopically. CONCLUSIONS: EUS-FNB using a 20-gauge ProCore needle is a technically feasible and effective modality for histopathologic diagnosis of gastrointestinal SETs, providing adequate core samples with fewer needle passes;ClinicalTrials.gov number, NCT02884154.