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

Summary

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.

Eligibility

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.

Conditions2

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