Superficial non-ampullary duodenal epithelial tumors measuring 20 mm or less
Conditions
Interventions
A: Conventional EMR group
B: Under-water EMR group
Sponsors
Tohoku University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Endoscopically diagnosed as adenoma or adenocarcinoma, or histologically confirmed as adenoma or adenocarcinoma through preoperative biopsy. 2) Lesion with a longitudinal diameter of 20mm or less. 3) Estimated tumor depth is limited to the mucosa. 4) Lesion is located in either the duodenal bulb, descending part, or horizontal part, without invasion into the major papilla or minor papilla. 5) Lesion is non-pedunculated. 6) Scheduled for endoscopic treatment for a single lesion. 7) No history of gastrectomy or duodenectomy. 8) Patient's age at the time of registration is 18 years or older and 85 years or younger. 9) Performance Status (ECOG) is 0, 1, or 2. 10) Has received adequate explanation regarding trial participation and has provided written consent.
Exclusion criteria
Exclusion criteria: 1) Diagnosed with familial adenomatous polyposis (FAP). 2) Presents with systemic infections requiring systemic treatment. 3) Pregnant or breastfeeding women. 4) Complicated with psychiatric disorders, psychiatric symptoms, or dementia that would hinder participation in the trial. 5) Complicated with unstable angina (occurrence within the last 3 weeks or exacerbation of angina) or a history of myocardial infarction within the past 6 months. 6) Patients taking multiple antithrombotic drugs, for whom endoscopy is preferably delayed according to the guidelines for gastrointestinal endoscopic treatment of patients on antithrombotic agents. 7) Complicated with respiratory diseases requiring continuous oxygen therapy. 8) Cases with a prognosis of less than 1 year. 9) Other cases deemed inappropriate by the attending trial physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) En-bloc resection rate 2) Histologically complete resection rate (en-bloc resection with HM0 and VM0) 3) Adverse events (perforation, postoperative bleeding, etc.) 4) Technical success rate 5) Total procedure time 6) Resection time 7) Suturing time 8) Rate of complete suturing 9) Rate of complete suturing with conventional clips 10) 1-year duodenum preservation survival rate 11) Cost of the equipment used | — |
Countries
Japan
Contacts
Public ContactMasao Yoshida
Shizuoka Cancer Center Division of Endoscopy
Outcome results
None listed