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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with microdialysis | Active Comparator | 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. |
|
| Patient without microdialysis | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical og radiological intervention, antibiotics | Procedure | Intervention might be a new drainage catheter, replacement of old drainage catheter, reoperation, somatostatin- and antibiotic administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Total hospital stay | Number of days from end of surgery to hospital discharge (at any hospital) | 30 days after surgery - postoperative day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay at the primary hospital | Length of stay at the primary hospital and ICU. Number of days from initial operation to primary hospital discharge. | 30 days after surgery - postoperative day 30 |
| Concentration of Lactate (mM), Pyruvate (microM), Glycerol (microM), Glucose (mM) in microdialysate |
| Measure | Description | Time Frame |
|---|---|---|
| Time before postoperative fistula is diagnosed (hours) | Hours from end of surgery to diagnosis of postoperative pancreatic fistula | End of surgery to 30 days postoperative |
| Total quantity (μg/mg) of vasoactive medications at discharge at an average of 10 days after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Espen Lindholm, ph.d | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33962656 | Derived | Lindholm E, Ekiz N, Tonnessen TI. Monitoring of patients with microdialysis following pancreaticoduodenectomy-the MINIMUM study: study protocol for a randomized controlled trial. Trials. 2021 May 7;22(1):329. doi: 10.1186/s13063-021-05221-9. |
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No plan for individual participant data (IPD).
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| D004379 | Duodenal Neoplasms |
| D010185 | Pancreatic Fistula |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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2-armed, multicenter, randomized, open label, parallel-group controlled trial (RCT)
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Concentration of Lactate, Pyruvate, Glycerol, Glucose in microdialysate in relation to patients with or without anastomosis leakage |
| 30 days after surgery - postoperative day 30 |
| Concentration of inflammatory markers in microdialysate | Concentration of inflammatory markers in microdialysate in relation to patients with or without anastomosis leakage | 30 days after surgery - postoperative day 30 |
| Concentration of inflammatory markers in serum | Concentration of inflammatory markers in serum in relation to patients with or without anastomosis leakage | 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 | Total score - Abdominal surgery Impact scale. The summative scores for the scale range from 18 to 126, with higher scores indicating better quality of life | From inclusion to 90-days after surgery |
| Patient-reported quality of life questionnaire - subgroup score Physical limitations assessed by the Abdominal surgery Impact scale | Subgroup score Physical limitations - Abdominal surgery Impact scale. The summative scores for the scale range from 3 to 18, with higher scores indicating better physical ability | From inclusion to 90-days after surgery |
| Patient-reported quality of life questionnaire - subgroup score Functional impairment assessed by the Abdominal surgery Impact scale | Subgroup score Functional impairment - Abdominal surgery Impact scale. The summative scores for the scale range from 3 to 18, with higher scores indicating better functional ability | From inclusion to 90-days after surgery |
| Patient-reported quality of life questionnaire - subgroup score Pain assessed by the Abdominal surgery Impact scale | Subgroup score Pain - Abdominal surgery Impact scale. The summative scores for the scale range from 3 to 18, with higher scores indicating more pain | From inclusion to 90-days after surgery |
| Patient-reported quality of life questionnaire - subgroup score Visceral Function assessed by the Abdominal surgery Impact scale | Subgroup score Visceral Function - Abdominal surgery Impact scale. The summative scores for the scale range from 3 to 18, with higher scores indicating more Visceral dysfunction | From inclusion to 90-days after surgery |
| Patient-reported quality of life questionnaire - subgroup score Sleep assessed by the Abdominal surgery Impact scale | Subgroup score Sleep - Abdominal surgery Impact scale. The summative scores for the scale range from 3 to 18, with higher scores indicating more sleep dysfunction | From inclusion to 90-days after surgery |
| Patient-reported quality of life questionnaire - subgroup score Psychological function assessed by the Abdominal surgery Impact scale | Subgroup score Psychological function - Abdominal surgery Impact scale. The summative scores for the scale range from 3 to 18, with higher scores indicating more psychological dysfunction | From inclusion to 90-days after surgery |
| Patient-reported pain questionnaire - total score assessed by the McGill Pain Questionnaire-2 (SF-MPQ-2) | Total score - McGill Pain Questionnaire-2 (SF-MPQ-2). Subgroup score Psychological function - Abdominal surgery Impact scale. The summative scores ranging from 0 to 45, with higher score indicating more pain | From inclusion to 90-days after surgery |
| Expenses (Euros) per patient used during total hospital stay | Number of Euros used in patient undergoing pancreaticoduodenectomy With or without microdialysis catheter | 30 days after surgery - postoperative day 30 |
| Daily assessement of microdialysis catheter malfunction during admission at hospital, at an average of 10 days after surgery | Number of catheter which are not functioning | From surgery end to discharge from primary hospital, at an average of 10 days after surgery |
| Risk factors of postoperative pancreatic fistula at discharge from hospital, at an average 10 days after surgery | Numbers of risk factors of postoperative pancreatic fistula in relation to patients with or without anastomosis leakage | 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 | Numbers of risk factors of postoperative pancreatic fistula in relation to patients with or without anastomosis leakage | From surgery end to 30 days after surgery |
| Risk factors of postoperative pancreatic fistula at 90 days after surgery | Numbers of risk factors of postoperative pancreatic fistula in relation to patients with or without anastomosis leakage | From surgery end to 90 days after surgery |
Amount of vasoactive medication during surgery and postoperatively until discharge from the hospital where the surgery was performed. |
| From surgery end to discharge from primary hospital at an average of 10 days after surgery |
| Number of patients with Pancreatic Fistula | Number of patients with Pancreatic Fistula | 30 days after surgery - postoperative day 30 |
| Number of patients with Biliary Fistula | Number of patients with Biliary Fistula | 30 days after surgery - postoperative day 30 |
| Number of patients with gastroenteric Fistula | Number of patients with gastroenteric Fistula | 30 days after surgery - postoperative day 30 |
| 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 | Pancreatic amylase and bilirubin concentrations in drainage fluid and in serum | From surgery end to discharge from primary hospital at an average of 10 days after surgery |
| Postoperative complications | Number of patients with postoperative complications during total hospital stay | From inclusion to 90-days after surgery |
| Fluid Balance (ml) during hospital admission at an average of 10 days after surgery | Diuresis and amount of fluid given i.v. during surgery and postoperatively until discharge from the primary hospital | From anesthesia start to discharge from primary hospital at an average of 10 days after surgery |
| Number of patients discharged to home/self care at an average of 10 days after surgery | Patient's discharge disposition - number of patients Discharged to home/self care | At discharge at an average of 10 days after surgery |
| Number of patients discharged to home but with home health service at an average of 10 days | Patient's discharge disposition - number of patients Discharged to home but with home health service | At discharge at an average of 10 days after surgery |
| Number of patients discharged/transferred to nursing home at an average of 10 days | Patient's discharge disposition - number of patients Discharged/transferred to nursing home | At discharge at an average of 10 days after surgery |
| Number of patients discharged/transferred to an inpatient rehabilitation facility at an average of 10 days | Discharged to an inpatient rehabilitation facility | At discharge at an average of 10 days after surgery |
| Number of patients expired at an average of 10 days | Patient's discharge disposition - expired | At discharge at an average of 10 days after surgery |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001660 | Biliary Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D016154 | Digestive System Fistula |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |