A comparison of novel electrocautery-enhanced lumen-apposing metal stents and plastic stents in EUS-guided drainage of infected walled-off necrosis: A multicenter randomized study

Background and study aims: Although lumen-apposing metal stents (LAMSs) have been increasingly used for walled-off necrosis (WON), their advantages over plastic stents (PS) in infected WON are unclear. We investigated the safety and efficacy of novel electrocautery-enhanced LAMS (EC-LAMS) for managing infected WON. Patients and methods: Patients who underwent endoscopic ultrasound-guided WON drainage were randomly assigned to the LAMS or PS groups. The primary outcome was the total number of direct endoscopic necrosectomy (DEN) procedures required to achieve clinical success. The secondary outcomes included technical success, clinical success, and adverse event occurrence. Results: Forty-six patients were divided into the LAMS or PS groups (n=23 each). The total number of DEN procedures did not differ significantly between the PS (four procedures, interquartile range [IQR] 2.5–5.0) and LAMS groups (nine procedures, IQR: 8.0–9.0) (P=0.07). The LAMS group demonstrated a significantly higher clinical success rate than the PS group based on intention-to-treat analysis (100% vs. 73.9%, P=0.03) at 8 weeks but not at 4 weeks. No significant bleeding events were reported in the LAMS group, and one was reported in the PS group. Conclusions: We found no significant difference in the total number of DEN procedures between LAMS and PS for managing infected WON. The only statistically significant finding was a higher clinical success rate at 8 weeks for patients treated with EC-LAMS. The use of EC-LAMS did not result in any adverse events, such as bleeding or buried LAMS syndrome, within the study duration.