Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study

Esophageal Self-expandable Metal Stent for Malignant Strictures: a Safety and Efficacy Study

A single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.

Objective: To assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (SEMS) for palliation of patients with malignant dysphagia.

Study design: Single center prospective observational non-randomized clinical study.

Study population: A total of 20 patients with malignant dysphagia will be included. Sample size calculation does not apply for this type of study. Outcome of the study (efficacy and safety) will be compared to our historic esophageal stent database, including over 1000 patients.

Inclusion Criteria:

• Patients presenting with dysphagia due to a non-curable 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;
• Written informed consent;
• Age ≥ 18 years.

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;
• Coagulopathy (not corrected prior to stent placement);
• Patients with eosinophilic esophagitis or an esophageal motility disorder;
• Nickel titanium (Nitinol) allergy.