superficial duodenal epithelial tumor duodenal neoplasm
Conditions
Interventions
Sponsors
Yoshii Shunsuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of duodenal adenoma or intramucosal adenocarcinoma by preoperative endoscopic forceps biopsy or endoscopic observation Tumor of the papilla of Vater or superficial non-ampullary duodenal epithelial tumors of 2 cm or larger in diameter and located at the anal side of supraduodenal angle Age is 18 or over No severe organ dysfunction Performance Status (ECOG) is 0, 1 or 2 Written informed consent are obtained
Exclusion criteria
Exclusion criteria: Active other organ cancer that cannot be cured Poorly controlled diabetes mellitus Continuous use of Cyclosporin or Bromocriptine Severe psychiatric disease Active infectious disease Pregnant or possibly pregnant Participating in other interventional study Patients judged inappropriate by investigator or attending doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative adverse events within 28 days after procedure Cohort A: postoperative (delayed) perforation or postoperative bleeding Cohort B: postoperative (delayed) perforation, postoperative bleeding, or postoperative pancreatitis | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of intraoperative adverse events Incidence of overall adverse events Incidence of adverse events related to study drug Fasting period Length of hospital stay Glycemic response to study drug | — |
Contacts
Public ContactYugo Kai
Osaka International Cancer Institute
Outcome results
None listed