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Набор скоро начнётся NCT07540975

Postoperative Insulin Intervention After Pancreatectomy in nDM Patients

Без фазы С лечением Postoperative Hyperglycemia Pancreatectomy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Insulin Infusion, No Insulin Infusion (Standard Monitoring Only).
Кому может быть актуально
Состояния в реестре: Postoperative Hyperglycemia, Pancreatectomy. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effects of Insulin Intervention After Pancreatectomy in Preoperative Non-diabetic Patients : Randomized Non-inferiority Clinical Trial

Обзор

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.

Вмешательства

  • Препарат 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/dL). Insulin infusion is continued until postoperative day 2 (9 AM) unless discontinued earlier due to hypoglycemia or clinical indication.
  • Другое 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/dL for two consecutive days, rescue insulin therapy is initiated according to institutional protocol. All other perioperative care follows standard postoperative management.

Первичные конечные точки

  • Mean Blood Glucose Level (Average of Daily Mean Values from Postoperative Day 0 to 3) [Срок оценки: From postoperative day 0 through postoperative day 3]
Вторичные конечные точки (7)
  • Mean Blood Glucose Level on Postoperative Day 0 [Срок оценки: Postoperative day 0]
  • Mean Blood Glucose Level on Postoperative Day 1 [Срок оценки: Postoperative day 1]
  • Mean Blood Glucose Level on Postoperative Day 2 [Срок оценки: Postoperative day 2]
  • Mean Blood Glucose Level on Postoperative Day 3 [Срок оценки: Postoperative day 3]
  • Postoperative Blood Glucose Variability [Срок оценки: From postoperative day 0 through postoperative day 3]
  • Incidence of Hypoglycemia [Срок оценки: From postoperative day 0 through postoperative day 3]
  • Incidence of Surgical Site Infection (SSI) [Срок оценки: Within 3 months after surgery]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 1 центр
  • Asan medical center — Seoul

Идентификаторы

NCT: NCT07540975 · 2021-1708

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗