Technical feasibility and safety of Underwater endoscopic mucosal resection versus Cold snare polypectomy for superficial non-ampullary Duodenal epithelial tumor; A randomized control trials.
Not Applicable
Recruiting
- Conditions
- Superficial non-ampullary duodenal epithelial tumor
- Registration Number
- JPRN-UMIN000039061
- Lead Sponsor
- Keio University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with multiple duodenal tumors associated with Familiar adenomatous polyposis and hereditary non-polyposis colorectal cancer 2) Patients who strongly suspect cancer / high grade adenoma in preoperative examination and biopsy 3) Patients who have undergone surgery for the upper gastrointestinal tract 4) Patients with blood coagulation dysfunction, patients who cannot manage anticoagulant / antiplatelet agents according to the guidelines for medical treatment of gastrointestinal endoscopy 5) Severe organ failure case 6) Cases determined by the attending physician to be inappropriate for registration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint is the percentage of complete pathological resection (negative horizontal and vertical resection margins and proportion of resected specimens with submucosa).
- Secondary Outcome Measures
Name Time Method Secondary endpoints include en bloc resection rate, R0 resection rate, resected lesion diameter, treatment time, pathological evaluation of resected lesions (resection thickness, resection distance, presence or absence of mucosal muscle plate, presence or absence of submucosal layer), accidental occurrence (bleeding, perforation, etc.) And the rate of remnants and recurrences after 6 months.