MINIMUM: Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy

Sponsor
Oslo University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03631173
Collaborator
(none)
201
1
2
45
4.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surgical og radiological intervention, antibiotics
N/A

Detailed Description

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
201 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
2-armed, multicenter, randomized, open label, parallel-group controlled trial (RCT)2-armed, multicenter, randomized, open label, parallel-group controlled trial (RCT)
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy - a Randomized Controlled Trial. THE MINIMUM STUDY
Actual Study Start Date :
Apr 2, 2019
Actual Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/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 intervene based on traditional symptoms and signs plus predetermined values of the microdialysis results.

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.

Outcome Measures

Primary Outcome Measures

  1. Total hospital stay [30 days after surgery - postoperative day 30]

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

Secondary Outcome Measures

  1. Length of stay at the primary hospital [30 days after surgery - postoperative day 30]

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

  2. Concentration of Lactate (mM), Pyruvate (microM), Glycerol (microM), Glucose (mM) in microdialysate [30 days after surgery - postoperative day 30]

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

  3. Concentration of inflammatory markers in microdialysate [30 days after surgery - postoperative day 30]

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

  4. Concentration of inflammatory markers in serum [30 days after surgery - postoperative day 30]

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

  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]

    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

  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]

    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

  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]

    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

  8. Patient-reported quality of life questionnaire - subgroup score Pain assessed by the Abdominal surgery Impact scale [From inclusion to 90-days after surgery]

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

  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]

    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

  10. Patient-reported quality of life questionnaire - subgroup score Sleep assessed by the Abdominal surgery Impact scale [From inclusion to 90-days after surgery]

    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

  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]

    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

  12. Patient-reported pain questionnaire - total score assessed by the McGill Pain Questionnaire-2 (SF-MPQ-2) [From inclusion to 90-days after surgery]

    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

  13. Expenses (Euros) per patient used during total hospital stay [30 days after surgery - postoperative day 30]

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

  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]

    Number of catheter which are not functioning

  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]

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

  16. Risk factors of postoperative pancreatic fistula at 30 days after surgery [From surgery end to 30 days after surgery]

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

  17. Risk factors of postoperative pancreatic fistula at 90 days after surgery [From surgery end to 90 days after surgery]

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

Other Outcome Measures

  1. Time before postoperative fistula is diagnosed (hours) [End of surgery to 30 days postoperative]

    Hours from end of surgery to diagnosis of postoperative pancreatic fistula

  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]

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

  3. Number of patients with Pancreatic Fistula [30 days after surgery - postoperative day 30]

    Number of patients with Pancreatic Fistula

  4. Number of patients with Biliary Fistula [30 days after surgery - postoperative day 30]

    Number of patients with Biliary Fistula

  5. Number of patients with gastroenteric Fistula [30 days after surgery - postoperative day 30]

    Number of patients with gastroenteric Fistula

  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]

    Pancreatic amylase and bilirubin concentrations in drainage fluid and in serum

  7. Postoperative complications [From inclusion to 90-days after surgery]

    Number of patients with postoperative complications during total hospital stay

  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]

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

  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]

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

  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]

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

  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]

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

  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]

    Discharged to an inpatient rehabilitation facility

  13. Number of patients expired at an average of 10 days [At discharge at an average of 10 days after surgery]

    Patient's discharge disposition - expired

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oslo University Hospital Oslo Norway 0424

Sponsors and Collaborators

  • Oslo University Hospital

Investigators

  • Principal Investigator: Espen Lindholm, ph.d, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Espen Lindholm, Senior researcher, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT03631173
Other Study ID Numbers:
  • 2018/1334
First Posted:
Aug 15, 2018
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Espen Lindholm, Senior researcher, Oslo University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 1, 2022