Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy
MINIMUM
1 other identifier
interventional
201
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pancreatic-cancer
Started Apr 2019
Longer than P75 for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
April 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
ExpectedApril 28, 2026
April 1, 2026
2.3 years
July 9, 2018
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total hospital stay
Number of days from end of surgery to hospital discharge (at any hospital)
30 days after surgery - postoperative day 30
Secondary Outcomes (17)
Length of stay at the primary hospital
30 days after surgery - postoperative day 30
Concentration of Lactate (mM), Pyruvate (microM), Glycerol (microM), Glucose (mM) in microdialysate
30 days after surgery - postoperative day 30
Concentration of inflammatory markers in microdialysate
30 days after surgery - postoperative day 30
Concentration of inflammatory markers in serum
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
- +12 more secondary outcomes
Other Outcomes (13)
Time before postoperative fistula is diagnosed (hours)
End of surgery to 30 days postoperative
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
Number of patients with Pancreatic Fistula
30 days after surgery - postoperative day 30
- +10 more other outcomes
Study Arms (2)
Patient with microdialysis
ACTIVE COMPARATORIntervention 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 INTERVENTIONThe 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.
Interventions
Intervention might be a new drainage catheter, replacement of old drainage catheter, reoperation, somatostatin- and antibiotic administration.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Allergic to Voluven® (Fresenius Kabi AS, Halden, Norway) and contrast given during CT scan
- Another study interfering with current study
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oslo University Hospital
Oslo, 0424, Norway
Related Publications (1)
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.
PMID: 33962656DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Espen Lindholm, ph.d
Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior researcher
Study Record Dates
First Submitted
July 9, 2018
First Posted
August 15, 2018
Study Start
April 2, 2019
Primary Completion
August 1, 2021
Study Completion (Estimated)
June 30, 2028
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
No plan for individual participant data (IPD).