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Esophageal Multisegmented FCSEMS for Malignant Strictures — EATERS  

Oesophageal Cancer Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04415463
Study type Interventional
Source Radboud University Medical Center
Contact
Status Terminated
Phase N/A
Start date March 3, 2021
Completion date December 1, 2022
View Details
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