NL-OMON45573
Completed
Phase 4
Esophageal HILZO Covered self-expandable metal stent for palliation of malignant dysphagia: A Safety and Feasibility Study - HILZO-study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Non\-operable malignant obstruction of the esophagus or esophagogastric junction, extrinsic malignant compression, or recurrent malignant dysphagia after esophagectomy. A tumor is considered inoperable if the patient has local tumor infiltration in the surrounding organs, distant metastases or a poor general health due to serious concomitant disease.
- •Recurrent dysphagia after prior radiation with curative or palliative intent for esophageal or gastric cardia cancer.
- •Requiring treatment for dysphagia (dysphagia score of 2\-4, according to Ogilvie2\)
- •Written informed consent
- •Age \>\= 18 years
Exclusion Criteria
- •Inappropriate cultural level and understanding of the study.
- •Simultaneous participation in another clinical study
- •Life expectancy of less than 12 months
- •Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
- •Tumor length of more than 12cm
- •Coagulopathy
- •Previous stent placement for the same condition
Outcomes
Primary Outcomes
Not specified
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