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Предстои набиране Не е приложимо NCT07540975

Postoperative Insulin Intervention After Pancreatectomy in nDM Patients

Не е приложима фаза (напр. обсервационно)
Заболявания: Postoperative Hyperglycemia Pancreatectomy

Спонсор: Dae Wook Hwang

Налично на: БГ
Обобщение
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.
Кой може да участва
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
Интервенции
Insulin Infusion
DRUG
No Insulin Infusion (Standard Monitoring Only)
OTHER
Места на провеждане 1
Южна Корея (1)
Asan medical center
Seoul
Seo Hyun Kim, Study Coordinator
Технически детайли
Статус
Предстои набиране
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
18.05.2026
Крайна дата
31.03.2030
Регистрационен номер
NCT07540975
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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