NCT04415463

Esophageal Multisegmented FCSEMS for Malignant Strictures

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oesophageal Cancer
• Esophageal Stent Stenosis

Interventions

Type	Name	Description
DEVICE	Multisegmented fully covered self-expandable metal stent	Esophageal FC-SEMS

Timeline

• Start date: 2021-03-03
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-06-04
• Last updated: 2023-01-12

Locations

1 site across 1 country: Netherlands