Multisegmented esophageal fully covered self-expandable metal stent for palliation of malignant dysphagia: a prospective multicenter feasibility and safety study

Background and Aims A novel multisegmented esophageal fully covered self-expandable metal stent (FCSEMS) was designed to reduce stent migration that is seen in up to 30% of patients. We aimed to evaluate safety and efficacy of this multisegmented FCSEMS. Methods This multicenter prospective study aimed to include 30 patients undergoing palliative stent placement. Efficacy defined as technically successful stent placement and dysphagia scores and safety defined as (serious) adverse events ((S)AEs) were measured. Results The study was prematurely terminated due to safety concerns after including 23 patients (mean age 72 yrs (± 10); 78% male). Stent placement was technically successful in 21 patients (91%) and dysphagia scores had improved in all patients with successful stent placement. SAEs occurred in 16 (70%) patients. Stent-related mortality occurred in three patients (13%). Conclusion The multisegmented FCSEMS successfully treated malignant dysphagia. The study was however prematurely terminated because stent placement was associated with a relatively high SAE rate.(Clinical trial registration number: NCT04415463)