Esophageal Multisegmented FCSEMS for Malignant Strictures

Oesophageal Cancer Clinical Trial

— EATERS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04415463
• Other study ID #: NL73180.091.20
• Status: Terminated
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: January 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Stent Stenosis
• Oesophageal Cancer

Intervention

Device:
• Multisegmented fully covered self-expandable metal stent
Esophageal FC-SEMS

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Adverse events during follow-up	6 months
Primary	Technical success of stent placement	Technical success of stent placement	1 day
Secondary	Recurrent dysphagia	Ogilvie dysphagia score	6 months
Secondary	Functional outcome	WHO performance score	6 months
Secondary	Tissue ingrowth or overgrowth		6 months
Secondary	Pain related to esophageal stent	Measured using the Visual Analogue Scale (VAS)	6 months