Early Detection of Anastomotic Leakage by Microdialysis Catheters: An Observational Study on Pancreaticoduodenectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 主要终点
- Glycerol concentration postoperatively
研究概览
简要总结
Anastomotic leakage of the pancreatojejunostomy is often discovered with considerable delay, causing severe peritonitis, hemorrhage due to erosion of vessels, sepsis, and death. Microdialysis catheters can detect focal inflammation and ischemia, and has a potential for early detection of anastomotic leakage. This observational study will examine if monitoring with microdialysis catheters can detect anastomotic leakage after pancreaticoduodenectomy earlier than current standard of care.
详细描述
Pancreaticoduodenectomy (Whipple´s procedure) offers the only potential cure for patients with tumor in the head of the pancreas, bile duct or periampullary region. This procedure is associated with high perioperative and postoperative mortality and morbidity. Postoperative pancreatic fistulae (POPF) is the most feared complication, and is often discovered with significant delay resulting in development of organ dysfunction and sepsis. Current standard for clinical detection of POPF is limited and nonspecific.
Microdialysis catheters allow bedside measurements of metabolism such as lactate, pyruvate, glucose and glycerol. The method has a high sensitivity and specificity in detecting complications in several types of abdominal surgery. However, microdialysis used after pancreaticoduodenectomy is not well documented. This observational study examine if monitoring with microdialysis catheters can detect anastomotic leakage after pancreaticoduodenectomy earlier than current standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tumor in the head of the pancreas, the bile duct or the duodenum detected on a computed tomography (CT) scan or magnetic resonance imaging (MRI), and evaluated by a multidisciplinary team to be resectable with a pancreaticoduodenectomy.
- •Written informed consent was obtained before study enrollment.
排除标准
- •<18 years
- •patient with tumor which was not resectable
结局指标
主要结局
Glycerol concentration postoperatively
时间窗: Measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Glycerol concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Glucose concentration postoperatively
时间窗: Measured hourly after surgery during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Glucose concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Lactate concentration postoperatively
时间窗: Measured hourly after surgery during the first 24 hours after surgery and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Lactate concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Pyruvate concentration postoperatively
时间窗: Measured hourly after surgery during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
Pyruvate concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery
次要结局
未报告次要终点
研究者
Espen Lindholm
senior Researcher
Oslo University Hospital