Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy - a Randomized Controlled Trial. THE MINIMUM STUDY
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Total hospital stay
研究概览
简要总结
A pancreaticoduodenectomy is performed in patient with pancreatic cancer. The most common and serious complication is leakage between the intestine and the remnant pancreas after this procedure. It occurs in 20-30%. The result is often prolonged hospital and ICU stay, reoperations and deaths (3-5%). To detect a leakage early before the patient becomes seriously ill, thereby initiating treatment is therefore very important. By inserting a thin microdialysis catheter near the anastomosis between pancreas and intestine before closure of the abdominal wall, the investigators will analyze substances such as lactic acid, pyruvate, glycerol, etc. and if these substances may reveal anastomosis leakage at an early stage. Observational studies have shown that if a leakage occurs, glycerol concentration in the microdialysate will rise significant after few hours, and changes in lactic acid and pyruvate values will change as a sign of inflammation. The investigators want to conduct a randomized study comparing patients undergoing pancreaticoduodenectomy and using microdialysis in half of the included population.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •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
排除标准
- •Allergic to Voluven® (Fresenius Kabi AS, Halden, Norway) and contrast given during CT scan
- •Another study interfering with current study
研究组 & 干预措施
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.
干预措施: Surgical og radiological intervention, antibiotics (Procedure)
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.
结局指标
主要结局
Total hospital stay
时间窗: 30 days after surgery - postoperative day 30
Number of days from end of surgery to hospital discharge (at any hospital)
次要结局
- Concentration of Lactate (mM), Pyruvate (microM), Glycerol (microM), Glucose (mM) in microdialysate(30 days after surgery - postoperative day 30)
- Patient-reported quality of life questionnaire - subgroup score Pain assessed by the Abdominal surgery Impact scale(From inclusion to 90-days after surgery)
- Length of stay at the primary hospital(30 days after surgery - postoperative day 30)
- 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)
- Patient-reported quality of life questionnaire - subgroup score Sleep assessed by the Abdominal surgery Impact scale(From inclusion to 90-days after surgery)
- Patient-reported pain questionnaire - total score assessed by the McGill Pain Questionnaire-2 (SF-MPQ-2)(From inclusion to 90-days after surgery)
- Patient-reported quality of life questionnaire - subgroup score Physical limitations assessed by the Abdominal surgery Impact scale(From inclusion to 90-days after surgery)
- Expenses (Euros) per patient used during total hospital stay(30 days after surgery - postoperative day 30)
- Patient-reported quality of life questionnaire - subgroup score Functional impairment assessed by the Abdominal surgery Impact scale(From inclusion to 90-days after surgery)
- Concentration of inflammatory markers in serum(30 days after surgery - postoperative day 30)
- Patient-reported quality of life questionnaire - subgroup score Psychological function assessed by the Abdominal surgery Impact scale(From inclusion to 90-days after surgery)
- 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)
- Concentration of inflammatory markers in microdialysate(30 days after surgery - postoperative day 30)
- Patient-reported quality of life questionnaire - subgroup score Visceral Function assessed by the Abdominal surgery Impact scale(From inclusion to 90-days after surgery)
- 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)
- Risk factors of postoperative pancreatic fistula at 30 days after surgery(From surgery end to 30 days after surgery)
- Risk factors of postoperative pancreatic fistula at 90 days after surgery(From surgery end to 90 days after surgery)
研究者
Espen Lindholm
Senior researcher
Oslo University Hospital