Postoperative Insulin Intervention After Pancreatectomy in nDM Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDae Wook Hwang

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

290 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dae Wook Hwang

Lead sponsor

Asan Medical Center

Sponsor institution