Endoscopic ultrasound (EUS)-guided fine needle biopsy alone vs. EUS-guided fine needle aspiration with rapid onsite evaluation in pancreatic lesions: a multicenter randomized trial

Background Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is the standard in the diagnosis of solid pancreatic lesions, in particular when combined with rapid onsite evaluation of cytopathology (ROSE). More recently, a fork-tip needle for core biopsy (FNB) has been shown to be associated with excellent diagnostic yield. EUS-FNB alone has however not been compared with EUS-FNA+ROSE in a large clinical trial. Our aim was to compare EUS-FNB alone to EUS-FNA+ROSE in solid pancreatic lesions. Methods A multicenter, non-inferiority, randomized controlled trial involving seven centers was performed. Solid pancreatic lesions referred for EUS were considered for inclusion. The primary end point was diagnostic accuracy. Secondary end points included sensitivity/specificity, mean number of needle passes, and cost. Results 235 patients were randomized: 115 EUS-FNB alone and 120 EUS-FNA+ROSE. Overall, 217 patients had malignant histology. The diagnostic accuracy for malignancy of EUS-FNB alone was non-inferior to EUS-FNA+ROSE at 92.2% (95%CI 86.6%-96.9%) and 93.3% (95%CI 88.8%-97.9%), respectively ( P =0.72). Diagnostic sensitivity for malignancy was 92.5% (95%CI 85.7%-96.7%) for EUS-FNB alone vs. 96.5% (93.0%-98.6%) for EUS-FNA+ROSE ( P =0.46), while specificity was 100% in both. Adequate histological yield was obtained in 87.5% of the EUS-FNB samples. The mean (SD) number of needle passes and procedure time favored EUS-FNB alone (2.3 [0.6] passes vs. 3.0 [1.1] passes [ P <0.001]; and 19.3 [8.0] vs. 22.7 [10.8] minutes [ P =0.008]). EUS-FNB alone cost on average 45 US dollars more than EUS-FNA+ROSE. Conclusion EUS-FNB alone is non-inferior to EUS-FNA+ROSE and is associated with fewer needle passes, shorter procedure time, and excellent histological yield at comparable cost.