Early Detection of Anastomotic Leakage by Microdialysis Catheters
关键词
抽象
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.
日期
| 最后验证: | 07/31/2018 |
| 首次提交: | 07/08/2018 |
| 提交的预估入学人数: | 08/09/2018 |
| 首次发布: | 08/12/2018 |
| 上次提交的更新: | 08/09/2018 |
| 最近更新发布: | 08/12/2018 |
| 实际学习开始日期: | 09/30/2013 |
| 预计主要完成日期: | 03/30/2014 |
| 预计完成日期: | 06/30/2018 |
状况或疾病
干预/治疗
Procedure: Pancreaticoduodenectomy patients
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Pancreaticoduodenectomy patients All patients undergoing pancreaticoduodenectomy receive a microdialysis catheter before skin closure and will be monitored postoperatively for lactate, pyruvate, glucose and glycerol in the microdialysate at certain timepoints | Procedure: Pancreaticoduodenectomy patients A thin microdialysis catheter is implanted before skin closure after pancreaticoduodenectomy. Analyses of the microdialysate are done at certain timepoints postoperatively. No intervention is done based on the results. The patients are following standard of care. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 取样方式 | Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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. Exclusion Criteria: - <18 years - patient with tumor which was not resectable |
结果
主要结果指标
1. Glycerol concentration postoperatively [Measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery]
2. Glucose concentration postoperatively [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]
3. Lactate concentration postoperatively [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]
4. Pyruvate concentration postoperatively [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]
