[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634537":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":58,"collaborators":26,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":26,"overallStatus":81,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Asan Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"No Insulin Infusion Group","EXPERIMENTAL","Participants assigned to this group will not receive routine postoperative insulin infusion following pancreatectomy. Blood glucose will be monitored four times daily. If fasting blood glucose exceeds 180 mg\u002FdL for two consecutive days, rescue insulin therapy will be initiated according to institutional protocol. All other perioperative care will follow standard postoperative management.",[13],"Other: No Insulin Infusion (Standard Monitoring Only)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Insulin Infusion Group","ACTIVE_COMPARATOR","Participants assigned to this group will receive continuous insulin infusion following pancreatectomy according to institutional protocol. Blood glucose will be monitored every 2 hours initially, with adjustment of insulin infusion rate to maintain target glucose levels (typically 140-180 mg\u002FdL). Insulin infusion will be continued until postoperative day 2 (9 AM), unless discontinued earlier due to hypoglycemia or clinical indication.",[19],"Drug: Insulin Infusion",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Insulin Infusion","Continuous intravenous insulin infusion administered postoperatively according to institutional protocol. Blood glucose levels are monitored at regular intervals, and the infusion rate is adjusted to maintain target glucose levels (typically 140-180 mg\u002FdL). Insulin infusion is continued until postoperative day 2 (9 AM) unless discontinued earlier due to hypoglycemia or clinical indication.",[15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"No Insulin Infusion (Standard Monitoring Only)","Postoperative management without routine insulin infusion. Blood glucose levels are monitored four times daily. If fasting blood glucose exceeds 180 mg\u002FdL for two consecutive days, rescue insulin therapy is initiated according to institutional protocol. All other perioperative care follows standard postoperative management.",[9],[32],{"name":33,"affiliation":5,"role":34},"Dae Wook Hwang","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Mirang Lee, Dr","CONTACT","+81-10-3390-5026","effly5026@gmail.com",[42],{"facility":43,"status":26,"city":44,"state":26,"zip":45,"country":46,"countryCode":26,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Asan medical center","Seoul","05505","South Korea",{"type":48,"coordinates":49},"Point",[50,51],126.9784,37.566,{"lat":51,"lon":50},[54],{"name":55,"role":38,"phone":56,"phoneExt":26,"email":57},"Seo Hyun Kim, Study Coordinator","+82-2-3010-8667","ksh6136@amc.seoul.kr",{"type":59,"investigatorFullName":33,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Professor","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":72,"type":73},290,"ESTIMATED","INTERVENTIONAL",[76],"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.",[79,80],"Postoperative Hyperglycemia","Pancreatectomy","NOT_YET_RECRUITING","2026-04-15",{"date":84,"type":85},"2026-04-21","ACTUAL",{"date":87,"type":73},"2026-05-18",{"date":89,"type":73},"2030-03-31",{"name":33,"class":6},1]