Esophageal Multisegmented FCSEMS for Malignant Strictures

Study Overview
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Brief Summary
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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.

Official Title
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EsophageAl mulTisegmented Fully covERed Self-expandable Metal Stent for Malignant Strictures: a Safety and Feasibility Study (EATERS Study)

Conditions
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Oesophageal Cancer, Esophageal Stent Stenosis

Intervention / Treatment
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* Device: Multisegmented fully covered self-expandable metal stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FC-SEMS<br>Placement of multisegmented fully covered self-expandable metal stent | Device: Multisegmented fully covered self-expandable metal stent<br>* Esophageal FC-SEMS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Adverse events during follow-up | 6 months | 
| Technical success of stent placement | Technical success of stent placement | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent dysphagia | Ogilvie dysphagia score | 6 months | 
| Functional outcome | WHO performance score | 6 months | 
| Tissue ingrowth or overgrowth |  | 6 months | 
| Pain related to esophageal stent | Measured using the Visual Analogue Scale (VAS) | 6 months |