Superficial non-ampullary duodenal epithelial tumor
Conditions
Interventions
Regarding UEMR, the lumen is first evacuated and then saline is injected. Thereafter, the snare is placed on the lesion and strangled. After confirming that there is no tumor left on the margin, the l
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 20 years or older who are scheduled to undergo endoscopic treatment for lesions diagnosed as low-grade duodenal tumors of 12 mm or less in our department. If there are multiple lesions, only the largest lesion, which is 12 mm or less, shall be regarded as accurate and assigned. Regarding postoperative complications, if only the same lesion is involved and bleeding or perforation occurs in other lesions of multiple lesions, it is regarded as different.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the percentage of complete pathological resection (negative horizontal and vertical resection margins and proportion of resected specimens with submucosa). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactYoshiyuki Kiguchi
Keio University, school of medicine Cancer center, division of research and development for minimal invasive treatment
Outcome results
None listed