Background and Study Aims: EUS-guided fine needle aspiration (EUS-FNA) is the standard in the diagnosis of pancreatic solid lesions, in particular when combined with rapid on-site 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; however, has not been compared to EUS-FNA+ ROSE in a large clinical trial. Our aim is to compare EUS-FNB alone to EUS-FNA+ ROSE in solid pancreatic lesions.

Patients and Methods: Multicenter non-inferiority RCT involving 7 centers. Solid pancreatic lesions referred for EUS were considered for inclusion. The primary endpoint is diagnostic accuracy. Secondary endpoints include 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 a malignant histology. The diagnostic accuracy for malignancy of EUS-FNB alone was non-inferior to EUS-FNA+ ROSE 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%) EUS-FNB alone vs. 96.5%(93.0-98.6%) EUS-FNA+ ROSE (p= 0.46) while specificity was 100% in both. Adequate histology yield was obtained in 87.5% of the EUS-FNB alone samples. Mean number of needle of passes and procedure time favored EUSFNB alone (2.3±0.6 passes vs. 3.0±1.1 passes p≤ 0.01 and 19.3±8.0 minutes vs. 22.7±10.8 minutes p< 0.01). EUS-FNB alone cost