Clinical trialNANot yet recruiting
Postoperative Insulin Intervention After Pancreatectomy in nDM Patients
Effects of Insulin Intervention After Pancreatectomy in Preoperative Non-diabetic Patients : Randomized Non-inferiority Clinical Trial
- Outcome
- Ongoing
- Phase
- NA
- Status
- Not yet recruiting
- Study type
- Interventional
- Start
- 18 May 2026
- Expected end
- 31 March 2030
- Enrollment
- 290 participants
- Sites
- 1
- Primary outcomes
- Mean Blood Glucose Level (Average of Daily Mean Values from Postoperative Day 0 to 3)
- Sponsor
- Other
- Results posted
- No
- Last update
- 21 April 2026
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Brief summary public domain (ClinicalTrials.gov)
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.