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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04415463
Other study ID # NL73180.091.20
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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