Postoperative Insulin Intervention After Pancreatectomy in nDM Patients

Effects of Insulin Intervention After Pancreatectomy in Preoperative Non-diabetic Patients : Randomized Non-inferiority Clinical 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.

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