Neoplasms

Digestive System Diseases

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All Conditions

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Rare Diseases

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Fistula

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Pancreatic Fistula

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Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pathological Conditions, Anatomical

Biliary Tract Diseases

Digestive System Fistula

Intestinal Neoplasms

Duodenal Diseases

Intestinal Diseases

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Anti-Infective Agents

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Somatostatin

Antibiotics, Antitubercular

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.

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.

Intervention might be a new drainage catheter, replacement of old drainage catheter, reoperation, somatostatin- and antibiotic administration.

Surgical og radiological intervention, antibiotics

Espen Lindholm, ph.d

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).

2-armed, multicenter, randomized, open label, parallel-group controlled trial (RCT)

Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy

Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy - a Randomized Controlled Trial. THE MINIMUM STUDY

No plan for individual participant data (IPD).

Hours from end of surgery to diagnosis of postoperative pancreatic fistula

Amount of vasoactive medication during surgery and postoperatively until discharge from the hospital where the surgery was performed.

Number of patients with Pancreatic Fistula

Number of patients with gastroenteric Fistula

Pancreatic amylase and bilirubin concentrations in drainage fluid and in serum

Number of patients with postoperative complications during total hospital stay

Diuresis and amount of fluid given i.v. during surgery and postoperatively until discharge from the primary hospital

Patient's discharge disposition - number of patients Discharged to home/self care

Patient's discharge disposition - number of patients Discharged to home but with home health service

Patient's discharge disposition - number of patients Discharged/transferred to nursing home

Discharged to an inpatient rehabilitation facility

Patient's discharge disposition - expired

Number of days from end of surgery to hospital discharge (at any hospital)

Length of stay at the primary hospital and ICU. Number of days from initial operation to primary hospital discharge.

Concentration of Lactate, Pyruvate, Glycerol, Glucose in microdialysate in relation to patients with or without anastomosis leakage

Concentration of inflammatory markers in microdialysate in relation to patients with or without anastomosis leakage

Concentration of inflammatory markers in serum in relation to patients with or without anastomosis leakage

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

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

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

Subgroup score Pain - Abdominal surgery Impact scale. The summative scores for the scale range from 3 to 18, with higher scores indicating more pain

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

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

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

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

Number of Euros used in patient undergoing pancreaticoduodenectomy With or without microdialysis catheter

Number of catheter which are not functioning

Numbers of risk factors of postoperative pancreatic fistula in relation to patients with or without anastomosis leakage

Spots Global Cancer Trial Database for surgical og radiological intervention, antibiotics