Wallflex versus Egis stent for palliation of malignant dysphagia’
Recruiting
- Conditions
- malignant dysphagiamaligne dysfagie
- Registration Number
- NL-OMON28202
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 116
Inclusion Criteria
Dysphagia due to an inoperable malignant obstruction of the esophagus or gastric cardia.
•Dysphagia is defined as: dysphagia score of 2-4, according to Ogilvie
Exclusion Criteria
-Evidence of tumor growth within 2 cm of the upper esophageal sphincter
-Tumor length > 12 cm
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite clinical end point of recurrent dysphagia and major complications due to stent placement:<br /><br>- Recurrent dysphagia is defined as a dysphagia score of ≥ 2 (according to Ogilvie) as a result of stent dysfunction after initial improvement of dysphagia to < 2. Stent dysfunction is defined as stent migration, tumor in- or overgrowth or food bolus impaction objectified during upper endoscopy. <br /><br>- Major complications due to stent placement are defined as complications leading to hospitalization, unintended prolongation of hospitalization, death or repeat endoscopic intervention with a possible or definite association with stent placement as determined by the treating physician<br /><br>
- Secondary Outcome Measures
Name Time Method