The safety and efficacy of a metallic full-coverd stent for preventing stricture after endoscopic submucosal dissection for large esophageal neoplasm
Phase 1
- Conditions
- Superficial esophageal neoplasm which needs semicircumferential (more than three fourths of the circumference of the esophageal lumen) or circumferential ESD
- Registration Number
- JPRN-UMIN000007688
- Lead Sponsor
- TT Medical Center Tokyo, Gastroenterology division
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
1. The case where micro perforation occurs during ESD. 2. The case where the proximal side of the stent may reach pharynx. 3. Those who are suffering from severe diabetes mellitus. 4. Those who received radiation to their esophagus. 5. Those who have psychiatric disease and predicted to have difficulty in participating in this study. In addition, those who are judged to be inappropriate by doctors.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety (the incidence of severe complications) The efficacy (the number of required endoscopic balloon dilatation within three months after stent removal)
- Secondary Outcome Measures
Name Time Method