Status:
TERMINATED
Esophageal Multisegmented FCSEMS for Malignant Strictures
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Erasmus Medical Center
Conditions:
Oesophageal Cancer
Esophageal Stent Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 dy...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04415463
Start Date
March 3 2021
End Date
December 1 2022
Last Update
January 12 2023
Active Locations (1)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6500