An observational study to evaluate the efficacy of suturing mucosal defects post duodenal endoscopic submucosal dissectio
- Conditions
- superficial non-ampullary duodenal epithelial tumor
- Registration Number
- JPRN-UMIN000050513
- Lead Sponsor
- Keio University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 220
Not provided
(1) Patients with familial adenomatous polyposis (FAP) (2) Patients who are treated for multiple lesions at the same time (patients with multiple lesions, including those of other organs, can be included if only one lesion is treated during the protocol treatment period) (3) Patients with history of duodenal resection in the past (4) Patients with a distance of 10 mm or less between the lesion and the duodenal papilla or accessory papilla (5) Patients whose lesions involve the duodenal bulb on the oral side (6) Vital organ insufficiency (heart, lung, liver, kidney, bone marrow) (7) Patients who cannot be managed perioperatively with antithrombotic drugs according to the guidelines proposed by Japan Gastroenterological Endoscopy Society (8) Other patients considered by the attending physician to be ineligible for entry
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of delayed adverse events (bleeding, perforation) within 28 days postoperatively
- Secondary Outcome Measures
Name Time Method (1) Postoperative outcomes rate of delayed bleeding rate of delayed perforation rate of surgery due to adverse events rate of maintenance of complete sutures and the number of remaining clips at the second-look endoscopy 3-5 days after surgery (2) Healthcare economics length of hospital stay total medical cost of hospitalization