RESUMEN
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-FNAâ+âROSE in a large clinical trial. Our aim was to compare EUS-FNB alone to EUS-FNAâ+âROSE 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-FNAâ+âROSE. Overall, 217 patients had malignant histology. The diagnostic accuracy for malignancy of EUS-FNB alone was non-inferior to EUS-FNAâ+âROSE at 92.2â% (95â%CI 86.6â%-96.9â%) and 93.3â% (95â%CI 88.8â%-97.9â%), respectively (Pâ=â0.72). Diagnostic sensitivity for malignancy was 92.5â% (95â%CI 85.7â%-96.7â%) for EUS-FNB alone vs. 96.5â% (93.0â%-98.6â%) for EUS-FNAâ+âROSE (Pâ=â0.46), while specificity was 100â% in both. Adequate histological yield was obtained in 87.5â% 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 [Pâ<â0.001]; and 19.3 [8.0] vs. 22.7 [10.8] minutes [Pâ=â0.008]). EUS-FNB alone cost on average 45 US dollars more than EUS-FNAâ+âROSE. CONCLUSION: EUS-FNB alone is non-inferior to EUS-FNAâ+âROSE and is associated with fewer needle passes, shorter procedure time, and excellent histological yield at comparable cost.
