Comparison of two different lumen-apposing metal stents for endoscopic ultrasound-guided drainage of pancreatic fluid collections: A randomized controlled trial

Endoscopic ultrasound (EUS)-guided drainage represents the standard of care for the treatment of symptomatic pancreatic fluid collections (PFCs), i.e., pseudocysts (PC) and walled-off necrosis (WON).The introduction of lumen apposing metal stents (LAMSs) has substantially increased the ability to treat these collections, particularly necrotic collections. Indeed, LAMSs allow quick drainage of large collections and the creation of a window through which necrotic content can more easily be drained as compared to double plastic pigtail stents or, when needed, direct endoscopic necrosectomy (DEN) can be done. The two cautery enhanced LAMS currently available are the Hot-AXIOS and Hot-SPAXUS system. The concern for bleeding-related AEs after AXIOS placement has been shown by recent data from post-marketing surveillance from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE), which highlighted the relatively high number of reports of EC-AXIOS-related bleeding (32% cases). Recently, a retrospective multi-centre propensity matched comparison of AXIOS vs SPAXUS stents for treatment of PFCs has been published which revealed SPAXUS stents to have a lower overall bleeding rates and overall adverse events. Since there is no head-to-head prospective comparison to address this gap, this randomized-controlled trial (RCT) has been designed to compare the occurrence of overall bleeding rates between the Hot-Axios and the Hot-Spaxus stent, in patients with WON. In addition, the technical and clinical success and overall adverse event rates of the two stents will be also analysed and compared.