Recently, a third-generation FNB needle (SecureFlex, Olympus, Japan), featuring a dual-beveled front-cutting raptor tip, was introduced. We aimed to evaluate the diagnostic performance and safety of this needle in an international, multicenter, prospective study. 

Consecutive patients undergoing EUS-guided sampling using the SecureFlex EUS-FNB needle were enrolled across eight centers. The primary endpoint was diagnostic accuracy; secondary endpoints included adequacy, number of needle passes, and adverse events. Final diagnosis was based on surgical pathology or FNB findings with clinical/radiologic follow-up. Operators rated needle performance on a 5-point Likert scale evaluating insertion, flexibility, tip control, echogenicity, puncturability, and overall use.

Eighty-five patients (58.8% male, median age 68 [IQR 60-76]) were included. Targets included pancreatic masses (51.8%), lymph nodes (18.8%), subepithelial lesions (9.4%), liver lesions (8.2%), and other sites (11.8%); median lesion size was 25 [IQR 15-32] mm. Needle calibers used were 22G (58.8%), 19G (23.5%), and 25G (17.6%); sampling techniques included dry suction (37.6%%) slow-pull (29.4%), and wet suction (21.2%) and a combination of dry and wet suction (11.8%), respectively. MOSE was used in all cases and ROSE in 1 case; one pass was required in 38.8%, two in 49.4%, and ≥3 in 11.8% of cases. Sample adequacy was 98.8%; sensitivity and specificity for malignancy were 97.1% and 100%, with overall diagnostic accuracy of 97.6%. Four patients (4.7%) had mild adverse events (3 self-limiting bleeding, AGREE I; 1 mild acute pancreatitis, AGREE II, in a patient undergoing same-session ERCP with stent). Operator ratings were consistently high, with “excellent” or “very good” scores across needle insertion (74.1% and 25.9%), flexibility (85.9% and 14.1%), tip control (71.8% and 25.9%), echogenicity (72.9% and 22.4%), puncturability (67.1% and 32.9%), and overall performance (74.1% and 25.9%).

The new dual-beveled raptor-tip EUS-FNB needle demonstrated excellent accuracy and core procurement, with optimal safety. Physicians’ assessments were excellent in most cases in all domains across different centers and operators.