Pancreas
Endoscopy. 2022;54(1):4–12
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. The aim of this trial was to compare EUS-FNB alone to EUS-FNA + ROSE in solid pancreatic lesions.
Methods: A multicenter, non-inferiority, randomized controlled trial involving 7 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% confidence interval [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 versus 96.5% (95% CI: 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 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: Endoscopic ultrasound (EUS)-guided fine needle biopsy alone is non-inferior to EUS-guided fine needle aspiration combined with rapid onsite evaluation of cytopathology and is associated with fewer needle passes, shorter procedure time, and excellent histological yield at comparable cost.