Esophageal Multisegmented FCSEMS for Malignant Strictures

Overview

Objective: To assess the safety and feasibility of the implementation of the esophageal multisegmented fully covered self-expandable metal stent (SEMS) for the palliation of patients with malignant dysphagia. Study design: Prospective observational nonrandomized clinical study. Study population: A total of 30 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study. Intervention: All patients will be treated with the esophageal multisegmented fully covered SEMS. Primary end points: * Safety: complications and adverse events during follow-up with special attention to stent migration rates; * Efficacy: technical success of stent placement. Secondary end points: * Recurrent dysphagia including its cause; * Functional outcome: Ogilvie dysphagia score and WHO performance score (measured at baseline, 2 weeks and every 4 weeks until death/stent removal, or until a maximum of 6 months follow-up); * Tissue ingrowth or overgrowth (measured endoscopically every endoscopic evaluation during follow-up); * Pain related to esophageal stent.

Conditions