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Not yet recruiting Not applicable NCT07540975

Postoperative Insulin Intervention After Pancreatectomy in nDM Patients

No applicable phase (e.g. observational)
Conditions: Postoperative Hyperglycemia Pancreatectomy

Sponsor: Dae Wook Hwang

trial.available_in: БГ
Overview
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.
Who can participate
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
Interventions
Insulin Infusion
DRUG
No Insulin Infusion (Standard Monitoring Only)
OTHER
Locations 1
South Korea (1)
Asan medical center
Seoul
Seo Hyun Kim, Study Coordinator
Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
18.05.2026
Completion date
31.03.2030
Registry ID
NCT07540975
Source
clinicaltrials.gov
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