Placement of a triple‐layered covered versus uncovered metallic stent for palliation of malignant gastric outlet obstruction: A multicenter randomized trial

Background Usually, uncovered self‐expandable metallic stents ( SEMS ) are used for palliation of malignant gastric outlet obstruction ( GOO ). A triple‐layered covered SEMS is reported to be efficacious, but its performance has not been compared with uncovered SEMS . The present study is the first to compare the efficacy and safety of a triple‐layered covered versus uncovered SEMS . Patients and Methods A multicenter randomized study was conducted in two tertiary referral centers, with 62 eligible patients with symptomatic GOO to receive covered ( n  = 31) or uncovered SEMS ( n  = 31). The primary endpoint was SEMS patency, and secondary endpoints were success rate and adverse events after complete follow up. Results Both groups had a technical success rate of 100% and comparable clinical success rates ( P  = 0.67). There was nostatistically significant difference in stent patency and adverse events between the two groups ( P  = 0.52 and P  = 0.38, respectively). Although the occurrence rate of persistent obstructive symptoms was comparable ( P  = 0.42), that of recurrent obstructive symptoms was higher in the uncovered group (29% vs 3.6%, P  = 0.0125). Patient survival did not differ between groups ( P  = 0.34). Conclusion There was no statistically significant difference in stent patency, but use of a triple‐layered covered SEMS was associated with less frequent stent dysfunction more than 4 weeks after stenting, despite similar short‐term outcomes.