Comparison of Two Expandable Endoprosthesis for Benign Esophageal Disease
Recruiting
- Conditions
- non-malignant esophageal stenosis (esophageal narrowing)/ esophageal perforation (leak)10017943
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Patients, 18 years of age and older, referred for stent placement for benign esophageal disease.
Exclusion Criteria
Presence of an esophageal malignancy or extrinsic compression due to mediastinal malignancy.
Location of lesions at less than 4 cm from upper gastro-intestinal sphincter.
Lesions longer than 9 cm.
Patients who are unable to undergo endoscopy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary parameter of this study is the stent migration rate.</p><br>
- Secondary Outcome Measures
Name Time Method <p>o Technical outcome - defined as success of stent deployment at the required<br /><br>position.<br /><br>o Immediate functional outcome - defined as immediate clinical success in<br /><br>relief of dysphagia, or sealing of a perforation or fistula at 24 hours.<br /><br>o Re-intervention rate after stent removal.<br /><br>o Procedural complications.<br /><br>o Success of stent extraction.<br /><br>o Thirty-day mortality rate.</p><br>