Clinical Trial

Postoperative Insulin Intervention After Pancreatectomy in nDM Patients

Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07540975
Lead Sponsor Dae Wook Hwang
Conditions Postoperative Hyperglycemia, Pancreatectomy
Enrollment 290 participants
Start Date 2026-05-18
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-21