Effects of Insulin Intervention After Pancreatectomy in Preoperative Non-diabetic Patients : Randomized Non-inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Mean Blood Glucose Level (Average of Daily Mean Values from Postoperative Day 0 to 3)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
No Insulin Infusion Group
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/dL for two consecutive days, rescue insulin therapy will be initiated according to institutional protocol. All other perioperative care will follow standard postoperative management.
干预措施: No Insulin Infusion (Standard Monitoring Only) (Other)
Standard Insulin Infusion Group
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/dL). Insulin infusion will be continued until postoperative day 2 (9 AM), unless discontinued earlier due to hypoglycemia or clinical indication.
干预措施: Insulin Infusion (Drug)
结局指标
主要结局
Mean Blood Glucose Level (Average of Daily Mean Values from Postoperative Day 0 to 3)
时间窗: From postoperative day 0 through postoperative day 3
次要结局
- Mean Blood Glucose Level on Postoperative Day 0(Postoperative day 0)
- Mean Blood Glucose Level on Postoperative Day 1(Postoperative day 1)
- Mean Blood Glucose Level on Postoperative Day 2(Postoperative day 2)
- Mean Blood Glucose Level on Postoperative Day 3(Postoperative day 3)
- Postoperative Blood Glucose Variability(From postoperative day 0 through postoperative day 3)
- Incidence of Hypoglycemia(From postoperative day 0 through postoperative day 3)
- Incidence of Surgical Site Infection (SSI)(Within 3 months after surgery)
研究者
Dae Wook Hwang
Professor
Asan Medical Center