Esophageal Multisegmented FCSEMS for Malignant Strictures
Esophageal Multisegmented FCSEMS for Malignant Strictures
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;

 -  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.