Cases scheduled for pancreatoduodenectomy for resectable pancreatic cancer.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Cases diagnosed with resectable pancreatic cancer. (2) Cases scheduled for pancreatoduodenectomy. (3) The age at the time of consent acquisition is between 18 and 85 years. (4) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is 0 or 1. (5) Meets all the following conditions based on the latest preoperative test values within 30 days before registration: - White blood cell count: >=2,500/uL and =10/*10^4uL - AST (Aspartate Aminotransferase): <=100U/L - ALT (Alanine Aminotransferase): <=100U/L - Total bilirubin: <=2.0 mg/dL (or <=4.0 mg/dL for cases with biliary drainage due to jaundice) - Serum creatinine: <=1.5 mg/dL (6) Written consent for participation in the trial has been obtained from the patient.
Exclusion criteria
Exclusion criteria: (1) Cases undergoing pancreatic resection other than pancreatoduodenectomy (such as total pancreatectomy,distal pancreatectomy, central pancreatectomy, or local pancreatectomy). (2) Undergoing continuous glucose monitoring for diabetes. (3) Cases deemed unsuitable as subjects for this trial by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The glycemic variability levels measured during each period of the treatment course for pancreatic cancer patients: Glucose concentrations are measured every 15 minutes for up to 14 days in a single session. Measurements taken for three days or more per session are considered valid. (1) At registration (2) Post neoadjuvant therapy (3) Acute postoperative period (4) Discharge after surgery (5) During postoperative adjuvant therapy (6) After completion of postoperative adjuvant therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Association between glycemic variability and treatment adherence Presence of preoperative complications, impact on the initiation of NAC (Neoadjuvant Chemotherapy) Adherence to NAC Impact on the start of surgery Postoperative complications, impact on the initiation of adjuvant therapy after surgery Adherence to postoperative adjuvant therapy (2) Relationship between glycemic variability and clinical symptoms (weight changes, nutritional status[Alb, T-chol, Lymphocyte, PNI, NLR, PLR, CONUT) | — |
Contacts
Shizuoka Cancer Center