Safety concerns

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.

Inclusion criteria:

• Patients presenting with dysphagia due to a non-operable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients;
• Requiring treatment for dysphagia (Ogilvie score of 2-41);
• Life expectancy of less than 12 months.

Exclusion criteria:

• Stenosis after laryngectomy;
• Distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter;
• Esophageal fistula;
• Tumor length of more than 14 cm;
• Previous stent placement for the same condition;
• Inappropriate cultural level and understanding of the study;
• Coagulopathy;
• Patients with eosinophilic esophagitis or an esophageal motility disorder;
• Nickel titanium (Nitinol) allergy.