cancer of the esophagus esophageal cancer
Conditions
Interventions
Endoscopic placement and removal of the Niti-S Esophageal Covered Stent
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Above 18 years of age • Presenting with an esophageal or gastric cardia carcinoma, confirmed by a tumor histology report • Requiring treatment for severe dysphagia due to stenosis, as confirmed by an endoscopic examination • Patient is a candidate for esophageal surgery • Patient is prepared to sign a study-specific Informed Consent
Exclusion criteria
Exclusion criteria: - Device-related exclusion criteria : • Esophageal strictures of benign etiology • Active tumor bleeding lesions • Patients who are contraindicated for endoscopy and/or surgery, or related testing and/or medications • Esophageal strictures that need to be dilated to pass the endoscope or the stent delivery system • Patients with esophago-jejunostomy (following gastrectomy) • Patients with polypoid lesions;- Study-related exclusion criteria: • Patients presenting with a highly-positioned esophageal tumor lesion (tumor must be at least 5 cm from upper esophageal sphincter, and the proximal end of the stent must be at least 2 cm from cricopharyngeal muscle) • Patients with significant preexisting pulmonary or cardiac disease • Patients at risk of respiratory problems (as confirmed by neck region ultrasound), or requiring tracheo-bronchal stenting • Patients due for radiotherapy prior to surgery (stent to be placed at least 4 weeks after radiotherapy) • Patients unwilling and/or unable to submit to follow-up assessments • Patients unable to fill-out questionnaires • Patients who are not scheduled for surgery within 2 weeks to 4 months from the stent placement procedure • Concurrent treatment with an investigational device or drug within 4 weeks of stent placement • Patients with poor mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the study or mental retardation or language barrier such that the patient is unable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate in stent removal at each time interval (ITT population). | — |
Countries
Netherlands
Outcome results
None listed