Evaluation of a Novel Tapered Tip EUS-FNB Needle: A UK Multicentre Study

Introduction: A new core biopsy needle with a novel tapered stylet tip has been introduced for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB). The tapered point stylet is purported to improve ease of puncture, leading to improved tissue acquisition and accuracy. However, there are no data available in the published literature. The aim of this study was to compare the diagnostic performance of the tapered stylet needle with conventional end-cutting FNB needles for tissue acquisition from solid lesions. Methods: Patients who underwent EUS-FNB of a solid lesion using the tapered stylet FNB needle across four tertiary hepatopancreaticobiliary centres in the UK were included in the study. Demographic, clinical, and performance outcomes were included in the analysis. Diagnostic performance was compared with a similar cohort of patients who underwent EUS-FNB using standard end-cutting FNB needles with a blunt-tipped stylet. The primary outcome was accuracy for the diagnosis of malignancy. Results: A total of 270 patients were included for analysis; 129 patients (48%) had sampling with the novel tapered stylet tip needle, among which 50% were female, the median age was 69, 74% had pancreatic lesions, and 80% had a final diagnosis of malignancy; 141 control cases (52%) were included for comparison, among which 48% were female, the median age was 68, 67% had pancreatic lesions, and 72% had a final diagnosis of malignancy. The tapered stylet needle demonstrated a sensitivity of 90% and an NPV of 72% for the diagnosis of malignancy compared with 88% and 77% for controls (p = 0.147). The overall diagnostic accuracy of the tapered stylet needle was 92.2% compared with 91.5% for controls (p = 0.634). Conclusions: The novel tapered tip stylet FNB needle demonstrated comparable sensitivity, NPV, and diagnostic accuracy to conventional FNB needles. This is the first and largest study reporting results for this new needle. However, further large comparative studies are warranted to validate our results and to determine if the tapered stylet offers an advantage over the conventional design.