Comparison of the diagnostic performance of 2 core biopsy needles for EUS-guided tissue acquisition from solid pancreatic lesions.

ABSTRACT

BACKGROUND AND AIMS: A new core biopsy needle with a novel tip, opposing bevel, and sheath design has recently been introduced for EUS-guided fine-needle biopsy (FNB). The diagnostic utility of this needle for differentiating solid pancreatic masses is currently unknown. The aim of this study was to compare the diagnostic performance and yield for tissue acquisition from solid pancreatic lesions of the opposing bevel needle with those of a reverse bevel EUS-FNB needle. METHODS: Consecutive patients with solid pancreatic masses undergoing EUS-FNB using the opposing bevel (n = 101) and the reverse bevel (n = 100) core biopsy needles were included in the study. Final diagnosis was based on positive histology or at least 12 months of follow-up in cases with a negative biopsy. The primary outcome was the diagnostic performance of the 2 needles for malignant pancreatic masses. A secondary outcome was the diagnostic yield. RESULTS: Compared with the reverse bevel needle, using strict criteria the opposing bevel needle provided significantly higher sensitivity (71.1% vs 90.1%; P = .0006) and overall accuracy (74% vs 92%; I = 0.0006) for discriminating malignant from benign solid pancreatic masses. The proportion of samples classified as adequate for histologic analysis was 87% for the reverse bevel needle versus 99% for the opposing bevel needle (p = 0.002) Multivariate analysis controlling the needle gauge and site did not show any significant difference in accuracy and sensitivity between the 2 groups. There were no adverse events in either group. CONCLUSIONS: In this first, large, single-center preliminary cohort study, an EUS core biopsy needle with a novel tip, opposing bevel, and sheath design afforded substantially superior tissue yield and diagnostic performance compared with a reverse-bevel needle. If replicated by randomized controlled trials, our findings suggest that similarly designed needles could become the standard of care for EUS-guided tissue acquisition from solid pancreatic masses.