Esophageal Multisegmented FCSEMS for Malignant Strictures

Not Applicable

Terminated

• Conditions: Oesophageal Cancer; Esophageal Stent Stenosis
• Interventions: Device: Multisegmented fully covered self-expandable metal stent

• Registration Number: NCT04415463
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-04
• Study Start: 2021-03-03
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FC-SEMS	Multisegmented fully covered self-expandable metal stent	Placement of multisegmented fully covered self-expandable metal stent

Primary Outcome Measures

Name	Time	Method
Adverse events	6 months	Adverse events during follow-up
Technical success of stent placement	1 day	Technical success of stent placement

Secondary Outcome Measures

Name	Time	Method
Recurrent dysphagia	6 months	Ogilvie dysphagia score
Functional outcome	6 months	WHO performance score
Tissue ingrowth or overgrowth	6 months
Pain related to esophageal stent	6 months	Measured using the Visual Analogue Scale (VAS)

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands