Esophageal Multisegmented FCSEMS for Malignant Strictures (EATERS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Oesophageal Cancer; Esophageal Stent Stenosis
• Intervention / Treatment: Device: Multisegmented fully covered self-expandable metal stent

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lieke Koggel, Drs.; Phone Number: +316-25678774; Email: lieke.koggel@radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500
      • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FC-SEMS; Placement of multisegmented fully covered self-expandable metal stent	Device: Multisegmented fully covered self-expandable metal stent; Esophageal FC-SEMS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: June 1, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NL73180.091.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No