Postoperative Hyperglycemia, Pancreatectomy
Conditions
Brief summary
The goal of this randomized non-inferiority clinical trial is to evaluate whether routine postoperative insulin infusion can be safely omitted in preoperative non-diabetic adult patients undergoing pancreatectomy for periampullary or pancreatic tumors. The primary purpose is to determine whether withholding insulin infusion provides comparable glycemic control while reducing treatment-related burden and adverse events. The main questions it aims to answer are: * Does omission of postoperative insulin infusion result in non-inferior mean blood glucose levels through postoperative day (POD) 3 compared to standard insulin infusion? * Does omission of insulin infusion reduce the incidence of hypoglycemia without increasing postoperative complications, including surgical site infection within 3 months? Researchers will compare a no-insulin infusion group (intervention arm) with a standard insulin infusion group (control arm) to determine whether avoiding routine insulin infusion maintains comparable glycemic control while improving safety and patient comfort. Participants will: * Undergo pancreatectomy and be randomly assigned (1:1) to either receive standard insulin infusion or no routine insulin infusion postoperatively * Have blood glucose monitored using intermittent testing and continuous glucose monitoring (flash glucose monitoring system) * Receive protocol-based glycemic management, including rescue insulin if hyperglycemia occurs or discontinuation if hypoglycemia develops * Be followed for up to 3 months postoperatively to assess glycemic outcomes, hypoglycemic events, surgical site infection, and other postoperative complications * Complete a questionnaire assessing discomfort related to glucose monitoring and insulin administration This study aims to establish evidence-based postoperative glucose management strategies for non-diabetic patients undergoing pancreatectomy.
Interventions
DRUGInsulin Infusion
Continuous intravenous insulin infusion administered postoperatively according to institutional protocol. Blood glucose levels are monitored at regular intervals, and the infusion rate is adjusted to maintain target glucose levels (typically 140-180 mg/dL). Insulin infusion is continued until postoperative day 2 (9 AM) unless discontinued earlier due to hypoglycemia or clinical indication.
OTHERNo Insulin Infusion (Standard Monitoring Only)
Postoperative management without routine insulin infusion. Blood glucose levels are monitored four times daily. If fasting blood glucose exceeds 180 mg/dL for two consecutive days, rescue insulin therapy is initiated according to institutional protocol. All other perioperative care follows standard postoperative management.
Sponsors
Dae Wook Hwang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 to 80 years * Patients without a prior diagnosis of diabetes mellitus * Patients scheduled to undergo pancreatectomy for periampullary tumors or pancreatic tumors * Ability to understand the study and provide written informed consent
Exclusion criteria
* Patients diagnosed with pancreatic adenocarcinoma * Patients undergoing total pancreatectomy * Patients undergoing hepatopancreatoduodenectomy (HPD) or with a history of prior hepatectomy * Patients with severe comorbidities (e.g., liver cirrhosis, chronic kidney disease, or heart failure) * Patients currently enrolled in another clinical trial that may interfere with this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Blood Glucose Level (Average of Daily Mean Values from Postoperative Day 0 to 3) | From postoperative day 0 through postoperative day 3 |
Secondary
| Measure | Time frame |
|---|---|
| Mean Blood Glucose Level on Postoperative Day 0 | Postoperative day 0 |
| Mean Blood Glucose Level on Postoperative Day 1 | Postoperative day 1 |
| Mean Blood Glucose Level on Postoperative Day 2 | Postoperative day 2 |
| Mean Blood Glucose Level on Postoperative Day 3 | Postoperative day 3 |
| Postoperative Blood Glucose Variability | From postoperative day 0 through postoperative day 3 |
| Incidence of Hypoglycemia | From postoperative day 0 through postoperative day 3 |
| Incidence of Surgical Site Infection (SSI) | Within 3 months after surgery |
Countries
South Korea
Contacts
CONTACTMirang Lee, Dr
PRINCIPAL_INVESTIGATORDae Wook Hwang
Asan Medical Center
Outcome results
None listed