About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Insulin Infusion
- No Insulin Infusion (Standard Monitoring Only)
Treatment groups
Sponsors and collaborators
Dae Wook Hwang
Lead sponsor
Asan Medical Center
Sponsor institution