NL-OMON30726
Recruiting
Not Applicable
A new design metal stent, SX-Ella stent Esophageal HV, for the prevention of recurrent dysphagia due to migration or tissue overgrowth: a prospective follow-up study - SX-ELLA stent Esophageal HV for the prevention of recurent dysphagia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a.Inoperable malignant obstruction of the esophagus or cardia (a tumor is considered inoperable if the patient has local tumor infiltration in neighboring organs, distant metastases, or a poor general health due to serious concomitant disease).
- •b.Recurrent dysphagia after prior radiation with curative or palliative intent for esophageal cancer.
- •c.Signed informed consent.
Exclusion Criteria
- •a.Evidence of tumor within 2 cm of the upper esophageal sphincter.
- •b.Esophagotracheal or \-bronchial fistula or both.
- •c.Lesions longer than 12 cm.
- •d.WHO performance score of 4\.
- •e.Lack of fitness for sedation (including known allergies).
Outcomes
Primary Outcomes
Not specified
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