Mo1391 Comparing the Performance of EUS-Fine Needle Aspiration and EUS-Fine Needle Biopsy: a Multicenter, Randomized Clinical Trial

Abstract

using plastic stent (nZ9) or biflanged metal stent (nZ3) and seventy patients with walled-off pancreatic necrosis (WON) treated using one and more plastic stents (nZ27) or biflanged metal stent (nZ43) under EUS guidance. Technical and clinical success and adverse event were evaluated. In addition, we assessed re-intervention after the initial drainage and total cost of treatment tools. Result: In terms of PC, there was no statistical significant difference between PS group and BFMS group. The outcome of EUS-guided drainage for PC was technical and clinical success rate (each 100%), early adverse event (0% vs 33%, pZ0.07), and mortality rate(each 0%) . However, total cost was higher in BFMS group than PS group (159$ vs 325$, p! 0.001). In terms of WON, there was not also statistically significant difference: technical success rate (each 100%) and clinical success rate (92.6% vs 97.7%,pZ0.31), early adverse event rate (18.5% vs 7.0%, pZ0.14), mortality rate (7.4% vs 2.3%, pZ0.85), re-intervention rate (30% vs 46.5%, pZ0.16), and the mean number of sessions of additional procedure (4.1 vs 2.7, pZ0.14). Total cost was almost the same (286$ vs 359$,pZ0.14). However, total cost in re-intervention case was statistically higher in PS group than BFMS group (611$ vs 393$,pZ0.03). Conclusions: EUS-guided drainage using a plastic stent versus a novel biflanged metal stent placement for PC and WON were equally effective although there was tendency of decrease of early adverse event rate (especially bleeding from the cavity, severe adverse event) and mortality rate in BFMS group. In terms of cost-effectiveness, PS is more beneficial for the treatment of PC. However, BFMS is more beneficial for the treatment of complicated WON. Since there are several limitations because there was no control group and this was retrospective manner, randomized controlled studies including the cost analysis and hospital stay are warranted.