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Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy


2019-04-02


2021-08-01


2025-12-31


201

Study Overview

Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy

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).

  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Biliary Tract Cancer
  • Duodenal Cancer
  • Pancreatic Fistula
  • PROCEDURE: Surgical og radiological intervention, antibiotics
  • 2018/1334

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2018-07-09  

N/A  

2023-11-23  

2018-08-10  

N/A  

2023-11-27  

2018-08-15  

N/A  

2023-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic


Allocation:
Randomized


Interventional Model:
Parallel


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
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

PROCEDURE: Surgical og radiological intervention, antibiotics

  • 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.

Primary Outcome MeasuresMeasure DescriptionTime Frame
Total hospital stayNumber of days from end of surgery to hospital discharge (at any hospital)30 days after surgery - postoperative day 30
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Length of stay at the primary hospitalLength 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 microdialysateConcentration of Lactate, Pyruvate, Glycerol, Glucose in microdialysate in relation to patients with or without anastomosis leakage30 days after surgery - postoperative day 30
Concentration of inflammatory markers in microdialysateConcentration of inflammatory markers in microdialysate in relation to patients with or without anastomosis leakage30 days after surgery - postoperative day 30
Concentration of inflammatory markers in serumConcentration of inflammatory markers in serum in relation to patients with or without anastomosis leakage30 days after surgery - postoperative day 30
Patient-reported quality of life questionnaire - total score assessed by the Abdominal surgery Impact scale by summing subscoresTotal score - Abdominal surgery Impact scale. The summative scores for the scale range from 18 to 126, with higher scores indicating better quality of lifeFrom inclusion to 90-days after surgery
Patient-reported quality of life questionnaire - subgroup score Physical limitations assessed by the Abdominal surgery Impact scaleSubgroup score Physical limitations - Abdominal surgery Impact scale. The summative scores for the scale range from 3 to 18, with higher scores indicating better physical abilityFrom inclusion to 90-days after surgery
Patient-reported quality of life questionnaire - subgroup score Functional impairment assessed by the Abdominal surgery Impact scaleSubgroup score Functional impairment - Abdominal surgery Impact scale. The summative scores for the scale range from 3 to 18, with higher scores indicating better functional abilityFrom inclusion to 90-days after surgery
Patient-reported quality of life questionnaire - subgroup score Pain assessed by the Abdominal surgery Impact scaleSubgroup score Pain - Abdominal surgery Impact scale. The summative scores for the scale range from 3 to 18, with higher scores indicating more painFrom inclusion to 90-days after surgery
Patient-reported quality of life questionnaire - subgroup score Visceral Function assessed by the Abdominal surgery Impact scaleSubgroup score Visceral Function - Abdominal surgery Impact scale. The summative scores for the scale range from 3 to 18, with higher scores indicating more Visceral dysfunctionFrom inclusion to 90-days after surgery
Patient-reported quality of life questionnaire - subgroup score Sleep assessed by the Abdominal surgery Impact scaleSubgroup score Sleep - Abdominal surgery Impact scale. The summative scores for the scale range from 3 to 18, with higher scores indicating more sleep dysfunctionFrom inclusion to 90-days after surgery
Patient-reported quality of life questionnaire - subgroup score Psychological function assessed by the Abdominal surgery Impact scaleSubgroup score Psychological function - Abdominal surgery Impact scale. The summative scores for the scale range from 3 to 18, with higher scores indicating more psychological dysfunctionFrom 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 painFrom inclusion to 90-days after surgery
Expenses (Euros) per patient used during total hospital stayNumber of Euros used in patient undergoing pancreaticoduodenectomy With or without microdialysis catheter30 days after surgery - postoperative day 30
Daily assessement of microdialysis catheter malfunction during admission at hospital, at an average of 10 days after surgeryNumber of catheter which are not functioningFrom 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 surgeryNumbers of risk factors of postoperative pancreatic fistula in relation to patients with or without anastomosis leakageFrom 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 surgeryNumbers of risk factors of postoperative pancreatic fistula in relation to patients with or without anastomosis leakageFrom surgery end to 30 days after surgery
Risk factors of postoperative pancreatic fistula at 90 days after surgeryNumbers of risk factors of postoperative pancreatic fistula in relation to patients with or without anastomosis leakageFrom surgery end to 90 days after surgery

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Espen Lindholm, ph.d, Oslo University Hospital

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    • 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.