Pancreatic CancerMINIMUMNCT03631173
Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy
A study testing Surgical og radiological intervention, antibiotics in people with Pancreatic Cancer and Pancreatic Neoplasms, run by Oslo University Hospital at 1 site in Norway.
Trial 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%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Neoplasms, Biliary Tract Cancer
- What is being tested?
- Surgical og radiological intervention, antibiotics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteNorway
- Study dates
- 2 Apr 2019to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Allergic to Voluven® (Fresenius Kabi AS, Halden, Norway) and contrast given during CT scan
- Another study interfering with current study
- Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy - a Randomized Controlled Trial. THE MINIMUM STUDY
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.
Read the 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).
- Conditions
- Pancreatic Cancer, Pancreatic Neoplasms, Biliary Tract Cancer, Duodenal Cancer, Pancreatic Fistula
- Being tested
- Surgical og radiological intervention, antibiotics
- Keywords
- Pancreaticoduodenectomy, Pancreatectomy, Anastomosis, Surgical
- Medical subject headings
- Pancreatic Neoplasms, Biliary Tract Neoplasms, Duodenal Neoplasms, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical og radiological intervention, antibioticsProcedure or surgery
Intervention might be a new drainage catheter, replacement of old drainage catheter, reoperation, somatostatin- and antibiotic administration.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Surgical og radiological intervention, antibiotics |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total hospital stay
Number of days from end of surgery to hospital discharge (at any hospital)
Measured: 30 days after surgery - postoperative day 30
Secondary outcomes (17)
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.
Measured: 30 days after surgery - postoperative day 30
Concentration of Lactate (mM), Pyruvate (microM), Glycerol (microM), Glucose (mM) in microdialysate
Concentration of Lactate, Pyruvate, Glycerol, Glucose in microdialysate in relation to patients with or without anastomosis leakage
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From surgery end to 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start2 Apr 2019
- Primary completion1 Aug 2021
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-armed, multicenter, randomized, open label, parallel-group controlled trial (RCT)
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Espen Lindholm, Oslo University Hospital
- Investigators
- Espen Lindholm, ph.d, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631173
- Sponsor's protocol ID
- 2018/1334
- Acronym
- MINIMUM
- Status last verified
- Apr 2026
- First submitted
- 9 Jul 2018
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan for individual participant data (IPD).
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.
PubMed 33962656
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy - a Randomized Controlled Trial. THE MINIMUM STUDY
- ClinicalTrials.gov ID
- NCT03631173
- Acronym / sponsor ID
- MINIMUM / 2018/1334
- Conditions
- Pancreatic Cancer, Pancreatic Neoplasms, Biliary Tract Cancer, Duodenal Cancer, Pancreatic Fistula
- Keywords
- Pancreaticoduodenectomy, Pancreatectomy, Anastomosis, Surgical
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 2 Apr 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-armed, multicenter, randomized, open label, parallel-group controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Patient with microdialysis | Active comparator | Procedure: Surgical og radiological intervention, antibioticsIntervention 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Allergic to Voluven® (Fresenius Kabi AS, Halden, Norway) and contrast given during CT scan
- Another study interfering with current study
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical og radiological intervention, antibioticsIntervention might be a new drainage catheter, replacement of old drainage catheter, reoperation, somatostatin- and antibiotic administration. | Procedure or surgery | Patient with microdialysis |
Primary outcome
Total hospital stay
Time frame: 30 days after surgery - postoperative day 30
Number of days from end of surgery to hospital discharge (at any hospital)
17 secondary outcomes
Length of stay at the primary hospital
Time frame: 30 days after surgery - postoperative day 30
Concentration of Lactate (mM), Pyruvate (microM), Glycerol (microM), Glucose (mM) in microdialysate
Time frame: 30 days after surgery - postoperative day 30
Concentration of inflammatory markers in microdialysate
Time frame: 30 days after surgery - postoperative day 30
Concentration of inflammatory markers in serum
Time frame: 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
Time frame: From inclusion to 90-days after surgery
Patient-reported quality of life questionnaire - subgroup score Physical limitations assessed by the Abdominal surgery Impact scale
Time frame: From inclusion to 90-days after surgery
Patient-reported quality of life questionnaire - subgroup score Functional impairment assessed by the Abdominal surgery Impact scale
Time frame: From inclusion to 90-days after surgery
Patient-reported quality of life questionnaire - subgroup score Pain assessed by the Abdominal surgery Impact scale
Time frame: From inclusion to 90-days after surgery
Patient-reported quality of life questionnaire - subgroup score Visceral Function assessed by the Abdominal surgery Impact scale
Time frame: From inclusion to 90-days after surgery
Patient-reported quality of life questionnaire - subgroup score Sleep assessed by the Abdominal surgery Impact scale
Time frame: From inclusion to 90-days after surgery
Patient-reported quality of life questionnaire - subgroup score Psychological function assessed by the Abdominal surgery Impact scale
Time frame: From inclusion to 90-days after surgery
Patient-reported pain questionnaire - total score assessed by the McGill Pain Questionnaire-2 (SF-MPQ-2)
Time frame: From inclusion to 90-days after surgery
Expenses (Euros) per patient used during total hospital stay
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From surgery end to 30 days after surgery
Risk factors of postoperative pancreatic fistula at 90 days after surgery
Time frame: From surgery end to 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Derived from this study: PubMed 33962656Lindholm 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.
- Individual participant dataSharing planned: No. No plan for individual participant data (IPD).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Espen Lindholm, ph.d principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical og radiological intervention, antibiotics in people with Pancreatic Cancer and Pancreatic Neoplasms, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total hospital stay (time frame: 30 days after surgery - postoperative day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03631173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.