superficial non-ampullary duodenal epithelial tumor
Conditions
Interventions
None listed
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)The lesion is located anal side than descending part of duodenum (lesions crossing the superior duodenal angle can be included). (2)The lesion size is less than 50 mm at preoperative evaluation. (3)Endoscopically suspected adenoma or adenocarcinoma (preoperative biopsy not required) (4)No endoscopic findings suggestive of submucosal invasion (5)Patients aged 20 to 85 years at the time of obtaining consent (6)Patients who give written consent to participate in this study
Exclusion criteria
Exclusion criteria: (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of delayed adverse events (bleeding, perforation) within 28 days postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactKurato Miyazaki
Keio University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine
Outcome results
None listed