Ampullary tumor Ampullary tumor
Conditions
Interventions
Sponsors
Kai Yugo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of duodenal adenoma or intramucosal adenocarcinoma by preoperative endoscopic forceps biopsy or endoscopic observation. In cases of adenocarcinoma, endoscopic observation or endoscopic ultrasound reveals that the cancer is confined to the mucosal layer. Age is 18 or over. No severe organ dysfunction. Performance Status (ECOG) is 0, 1 or 2. Written informed consent is obtained.
Exclusion criteria
Exclusion criteria: Poorly controlled diabetes mellitus. Continuous use of Cyclosporin or Bromocriptine. Active other organ cancer that cannot be cured. Severe psychiatric disease. Active infectious disease. Participating in other interventional study. Patients judged inappropriate by investigator or attending doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of postoperative complications (pancreatitis, hemorrhage, perforation) occurring within 30 days after endoscopic papillectomy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of intraoperative complications 2. Incidence of all complications within 30 days postoperatively 3. Incidence of treatment-related adverse events 4. Duration of fasting 5. Length of hospital stay 6. Changes in blood glucose levels before and after octreotide acetate administration | — |
Contacts
Public ContactShunsuke Yoshii
Osaka International Cancer Institute
Outcome results
None listed