pancreatic cancer
Conditions
Interventions
None listed
Sponsors
Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with pancreatic body cancer diagnosed as invasive ductal carcinoma (adenocarcinoma or adenosquamous carcinoma) based on histology, cytology, or imaging findings, and who, at initial diagnosis, underwent disease staging with multidetector computed tomography (MDCT), showing tumor abutment of the common hepatic artery (CHA), the celiac artery (CA), or located within 10 mm of the root of the splenic artery. 2. Patients receiving initial treatment (no prior therapy for pancreatic cancer). 3. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Patients aged >=20 years at the time of informed consent. 5. Patients with adequate organ function, as confirmed by laboratory values obtained within 30 days prior to enrollment: - White blood cell count: <=12,000 /mm3 - Neutrophil count: >=1,500 /mm3 - Hemoglobin: >=9.0 g/dL - Platelet count: >=100,000 /mm3 - Total bilirubin: <2.0 mg/dL (<=3.0 mg/dL if post-drainage for obstructive jaundice) - Serum creatinine: <=1.5 mg/dL - AST and ALT: <=2.5 x institutional upper limit of normal 6. Patients who have provided written informed consent prior to enrollment in this study.
Exclusion criteria
Exclusion criteria: 1. Patients with distant metastases, as defined by the NCCN Guidelines (Version 2.2025) for metastatic disease, based on staging by MDCT. 2. Patients with active infections. 3. Patients who did not provide written informed consent. 4. Patients deemed ineligible for participation in this study by the attending physician for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of major postoperative complications (Clavien-Dindo classification grade III or higher) within 90 days after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rate of completion of distal pancreatectomy with celiac artery preservation 2. R0 resection rate (rate of curative resection) 3. Overall survival from the start of neoadjuvant therapy 4. Recurrence-free survival from the start of neoadjuvant therapy 5. Overall survival from surgery 6. Recurrence-free survival from surgery 7. Surgical outcomes (operative time, intraoperative blood loss, need for transfusion, length of postoperative hospital stay) 8. Postoperative complication rates (reoperation rate, readmission rate, surgery-related mortality rate) 9. Response rate and disease control rate to preoperative chemotherapy (per RECIST version 1.1) 10. Normalization rate of tumor markers (CA19-9, CEA) before and after neoadjuvant chemotherapy 11. Histological treatment effect (tumor cell destruction rate based on Evans grading system) 12. Rate of initiation of postoperative adjuvant chemotherapy 13. Details of neoadjuvant therapy (duration, number of chemotherapy cycles, presence or absence of radiotherapy) 14. Disease-specific survival from the end of neoadjuvant therapy 15. Disease-specific survival from surgery 16. Patterns of recurrence 17. Postoperative weight loss rate (at 6 months, 1 year, 2 years, and 3 years after surgery) 18. Changes in postoperative performance status (ECOG scale) | — |
Countries
Japan
Contacts
Public ContactAkihiro Takeuchi
Wakayama Medical University Second Department of Surgery
Outcome results
None listed