[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"postoperative-hyperglycemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:postoperative-hyperglycemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100634537","postoperative-insulin-intervention-after-pancreatectomy-in-ndm-patients-100634537",false,"NCT07540975","Postoperative Insulin Intervention After Pancreatectomy in nDM Patients","Effects of Insulin Intervention After Pancreatectomy in Preoperative Non-diabetic Patients : Randomized Non-inferiority Clinical Trial","Inclusion Criteria:\n\n* Adults aged 18 to 80 years\n* Patients without a prior diagnosis of diabetes mellitus\n* Patients scheduled to undergo pancreatectomy for periampullary tumors or pancreatic tumors\n* Ability to understand the study and provide written informed consent\n\nExclusion Criteria:\n\n* Patients diagnosed with pancreatic adenocarcinoma\n* Patients undergoing total pancreatectomy\n* Patients undergoing hepatopancreatoduodenectomy (HPD) or with a history of prior hepatectomy\n* Patients with severe comorbidities (e.g., liver cirrhosis, chronic kidney disease, or heart failure)\n* Patients currently enrolled in another clinical trial that may interfere with this study","ALL","18 Years","80 Years",{"count":20,"type":21},290,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nThe main questions it aims to answer are:\n\n* Does omission of postoperative insulin infusion result in non-inferior mean blood glucose levels through postoperative day (POD) 3 compared to standard insulin infusion?\n* Does omission of insulin infusion reduce the incidence of hypoglycemia without increasing postoperative complications, including surgical site infection within 3 months?\n\nResearchers 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.\n\nParticipants will:\n\n* Undergo pancreatectomy and be randomly assigned (1:1) to either receive standard insulin infusion or no routine insulin infusion postoperatively\n* Have blood glucose monitored using intermittent testing and continuous glucose monitoring (flash glucose monitoring system)\n* Receive protocol-based glycemic management, including rescue insulin if hyperglycemia occurs or discontinuation if hypoglycemia develops\n* Be followed for up to 3 months postoperatively to assess glycemic outcomes, hypoglycemic events, surgical site infection, and other postoperative complications\n* Complete a questionnaire assessing discomfort related to glucose monitoring and insulin administration\n\nThis study aims to establish evidence-based postoperative glucose management strategies for non-diabetic patients undergoing pancreatectomy.",[27,28],"Postoperative Hyperglycemia","Pancreatectomy","NOT_YET_RECRUITING","2026-04-15",{"date":32,"type":33},"2026-04-21","ACTUAL",{"date":35,"type":21},"2026-05-18",{"date":37,"type":21},"2030-03-31",{"name":39,"class":40},"Dae Wook Hwang","OTHER"]