Abstract
BACKGROUND: This is a randomized study to compare the diagnostic accuracy of endoscopic ultrasound (EUS)-guided sampling of pancreatic solid lesions obtained with the 22-gauge Franseen (EUS-fine needle biopsy) vs the 22-gauge standard needle (EUS-fine needle aspiration) without rapid onsite evaluation (ROSE), since, in most endoscopy units around the world ROSE is not routinely available. AIM: To investigate the accuracy of EUS-guided sampling of pancreatic solid lesions obtained between two different needles without ROSE. METHODS: Patients with a solid pancreatic were included. Patients were biopsied in a randomized order. The primary endpoint was the diagnostic sensitivity for pancreatic malignancy (PM). Secondary outcomes were adequacy of the sample, the mean tissue area, the mean tumor area, and the adverse event rate. RESULTS: The final diagnosis was pancreatic adenocarcinoma in 38 (76%), neuroendocrine tumor in 4 (8%), chronic pancreatitis in 3 (6%) patients. The sensitivity for PM with Franseen needle was 0.91 [95% confidence interval (CI): 0.80-0.98], vs 0.8 (95%CI: 0.67-0.91) (P = 0.025) with standard needle. The specificity for PM did not differentiate. The accuracy of the standard needle for PM was 0.80 (95%CI: 0.66-0.90), and the Franseen group was 0.90 (95%CI: 0.78-0.97) (P = 0.074). The technical success rates for the standard and Franseen needle groups were 94% (95%CI: 0.83-0.99) and 100% (95%CI: 0.92-1.00), respectively. The mean total tissue area in mm(2) (SD) was greater in the Franseen group, 2.07 (0.22) vs 1.16 (0.17) (P < 0.01). The mean tumor area in mm(2) (SD) was not different in Franseen group vs standard group, 0.42 (0.09) vs 0.47 (0.09) (P = 0.80). There were no adverse events. CONCLUSION: The sensitivity for PM and mean total tissue area, was greater in the as compared with standard needle. The mean tumor area did not differ between the groups.