Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy
关键词
抽象
描述
Anastomotic leakage after pancreaticoduodenectomy is a feared complication with substantial mortality and morbidity. Treatment of a postoperative pancreatic fistula can be difficult and management may range from a simple observation with or without percutaneous drainage, to the urgent need for reoperation and management of abdominal sepsis with organ failure and prolonged intensive care. To diagnose a pancreatic fistula may have a delay of several days. The risk of death and severe morbidity raises considerable from a biochemical pancreatic fistula compared to the most serious form, a grade C. Also, the cost of managing a patient with a fistula is 1.3-6 times more than a patient with no complications after PD.
Microdialysis is a promising tool in patients who undergoes pancreaticoduodenectomy for early detection of postoperative pancreatic fistula development. The technique may reveal an fistula before severe symptoms occur and before the complication gives the patient serious and life-threatening symptoms. Earlier intervention of the postoperative pancreatic fistula may lead to better prognosis, less reoperations and interventions and shorter stay at the ICU/hospital. By monitoring intraperitoneal metabolites (glycerol, lactate, pyruvate and glucose) close to the pancreaticojejunostomy, signs of a leakage may be discovered in few hours, thereby make it possible for early intervention and prevent developement of serious progression of morbidity. The investigators want to perform a randomized study where half of the patients will receive a microdialysis catheter implanted close to the pancreaticoduodenal anastomosis before closure of the abdomen. At certain timepoints postoperatively microdialysate will be analyzed for glycerol, lactate, pyruvate and glucose and the data will be used in the decisionmaking of diagnosing a pancreatic anastomosis leakage in addition to standard management. The other half of the patients will not receive a microdialysis catheter and the decisionmaking will only be based on standard management (ie. inflammation markers in blood samples, amylase in drainage fluid).
日期
| 最后验证: | 03/31/2019 |
| 首次提交: | 07/08/2018 |
| 提交的预估入学人数: | 08/09/2018 |
| 首次发布: | 08/14/2018 |
| 上次提交的更新: | 04/01/2019 |
| 最近更新发布: | 04/03/2019 |
| 实际学习开始日期: | 03/17/2019 |
| 预计主要完成日期: | 05/31/2020 |
| 预计完成日期: | 10/31/2022 |
状况或疾病
干预/治疗
Procedure: Patient with microdialysis
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Patient with microdialysis Intervention group - Patients will receive an intraperitoneal microdialysis catheter and will be monitored consecutively by microdialysis. The surgeon is familiar with the current microdialysis results at any time during the study period. The surgeon may intervene based on traditional symptoms and signs plus predetermined values of the microdialysis results. | Procedure: Patient with microdialysis Intervention might be a new drainage catheter, replacement of old drainage catheter, reoperation, somatostatin- and antibiotic administration. |
| No Intervention: Patient without microdialysis The control group - The patients will not receive a microdialysis catheter. The patients are monitored according to current standards of care and the surgeon may intervene based only on traditional symptoms and signs. |
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 |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Patients must be scheduled for a pancreaticoduodenectomy - Subject must be ≥ 18 years - Able to give written signed informed consent - Investigator's assessment that the patient is able to understand, comply and follow the instructions needed to successfully participate in this trial Exclusion Criteria: - Allergic to Voluven® (Fresenius Kabi AS, Halden, Norway) and contrast given during CT scan - Another study interfering with current study - Pregnant |
结果
主要结果指标
1. Total hospital stay [30 days after surgery - postoperative day 30]
次要成果指标
1. Length of stay at the primary hospital [30 days after surgery - postoperative day 30]
2. Concentration of Lactate (mM), Pyruvate (microM), Glycerol (microM), Glucose (mM) in microdialysate [30 days after surgery - postoperative day 30]
3. Concentration of inflammatory markers in microdialysate [30 days after surgery - postoperative day 30]
4. Concentration of inflammatory markers in serum [30 days after surgery - postoperative day 30]
5. Patient-reported quality of life questionnaire - total score assessed by the Abdominal surgery Impact scale by summing subscores [From inclusion to 90-days after surgery]
6. Patient-reported quality of life questionnaire - subgroup score Physical limitations assessed by the Abdominal surgery Impact scale [From inclusion to 90-days after surgery]
7. Patient-reported quality of life questionnaire - subgroup score Functional impairment assessed by the Abdominal surgery Impact scale [From inclusion to 90-days after surgery]
8. Patient-reported quality of life questionnaire - subgroup score Pain assessed by the Abdominal surgery Impact scale [From inclusion to 90-days after surgery]
9. Patient-reported quality of life questionnaire - subgroup score Visceral Function assessed by the Abdominal surgery Impact scale [From inclusion to 90-days after surgery]
10. Patient-reported quality of life questionnaire - subgroup score Sleep assessed by the Abdominal surgery Impact scale [From inclusion to 90-days after surgery]
11. Patient-reported quality of life questionnaire - subgroup score Psychological function assessed by the Abdominal surgery Impact scale [From inclusion to 90-days after surgery]
12. Patient-reported pain questionnaire - total score assessed by the McGill Pain Questionnaire-2 (SF-MPQ-2) [From inclusion to 90-days after surgery]
13. Expenses (Euros) per patient used during total hospital stay [30 days after surgery - postoperative day 30]
14. Daily assessement of microdialysis catheter malfunction during admission at hospital, at an average of 10 days after surgery [From surgery end to discharge from primary hospital, at an average of 10 days after surgery]
15. Risk factors of postoperative pancreatic fistula at discharge from hospital, at an average 10 days after surgery [From surgery end to discharge from primary hospital at hospital, at an average of 10 days after surgery]
16. Risk factors of postoperative pancreatic fistula at 30 days after surgery [From surgery end to 30 days after surgery]
17. Risk factors of postoperative pancreatic fistula at 90 days after surgery [From surgery end to 90 days after surgery]
其他成果措施
1. Time before postoperative fistula is diagnosed (hours) [End of surgery to 30 days postoperative]
2. Total quantity (μg/mg) of vasoactive medications at discharge at an average of 10 days after surgery [From surgery end to discharge from primary hospital at an average of 10 days after surgery]
3. Number of patients with Pancreatic Fistula [30 days after surgery - postoperative day 30]
4. Number of patients with Biliary Fistula [30 days after surgery - postoperative day 30]
5. Number of patients with gastroenteric Fistula [30 days after surgery - postoperative day 30]
6. Daily measurements during hospital admission of pancreatic amylase (U/L) and bilirubin (µmol/L ) concentrations in drainage fluid and in serum, at an average og 10 days after surgery [From surgery end to discharge from primary hospital at an average of 10 days after surgery]
7. Postoperative complications [From inclusion to 90-days after surgery]
8. Fluid Balance (ml) during hospital admission at an average of 10 days after surgery [From anesthesia start to discharge from primary hospital at an average of 10 days after surgery]
9. Number of patients discharged to home/self care at an average of 10 days after surgery [At discharge at an average of 10 days after surgery]
10. Number of patients discharged to home but with home health service at an average of 10 days [At discharge at an average of 10 days after surgery]
11. Number of patients discharged/transferred to nursing home at an average of 10 days [At discharge at an average of 10 days after surgery]
12. Number of patients discharged/transferred to an inpatient rehabilitation facility at an average of 10 days [At discharge at an average of 10 days after surgery]
13. Number of patients expired at an average of 10 days [At discharge at an average of 10 days after surgery]
