NOT YET RECRUITING
NCT07540975
Postoperative Insulin Intervention After Pancreatectomy in nDM Patients
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.
Gender: All
Ages: 18 Years - 80 Years
Postoperative Hyperglycemia
Pancreatectomy