Use of a novel lumen apposing metallic stent for drainage of the bile duct and gallbladder: Long term outcomes of a prospective international trial.

Abstract

Long-term placement of lumen apposing metal stents (LAMS) with high lumen apposing force may result in adverse events. The aim of the current study was to assess the long-term efficacy and safety of a self-approximating LAMS with lower lumen apposing force for endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) and -gallbladder drainage (EUS-GBD). Five Asian institutions participated in this study. Consecutive patients suffering from obstructive jaundice with failed ERCP or acute cholecystitis that were at high risk for cholecystectomy were recruited. We evaluated the technical and clinical success rates, adverse events rates, types of interventions through the stent and the patency profile. From June 2017 to Oct 2018, a total of 53 patients received EUS-CDS (26) and EUS-GBD (27). The technical and clinical success rates were similar between the two groups (88.5% vs 88.9%, P=1 and 88.5% vs 88.9%, P=1 respectively). The differences in 30-day mortality rates [2 (7.7%) vs 2 (7.7%), P=1] and adverse events [3 (11.5%) vs 3 (11.5%), P=1] did not reach significance. Regarding long-term outcomes, two patients in each group suffered from adverse events (P=1). One patient in the EUS-GBD group who was on direct oral anticoagulant suffered from stent induced bleeding. The self-approximating LAMS with lower lumen apposing force was effective and safe with a low risk of buried stent syndrome and bleeding in the longer term. The ClinicalTrials.gov Identifier was NCT03002051.