Esophageal Stent Stenosis, Oesophageal Cancer
Conditions
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.
Interventions
DEVICEMultisegmented fully covered self-expandable metal stent
Esophageal FC-SEMS
Sponsors
Erasmus Medical Center
Radboud University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 6 months | Adverse events during follow-up |
| Technical success of stent placement | 1 day | Technical success of stent placement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Netherlands
Outcome results
None listed