4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy (MINIMUM)

Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy (MINIMUM)

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
Pancreatic Cancer Pancreatic Neoplasms Biliary Tract Cancer Duodenal Cancer Pancreatic Fistula Procedure: Surgical og radiological intervention, antibiotics Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 : April 2, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : November 1, 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 30 days after surgery - postoperative day 30 ]
    Number of patients with Pancreatic Fistula

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

  5. Number of patients with gastroenteric Fistula [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At discharge at an average of 10 days after surgery ]
    Patient's discharge disposition - expired


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Layout table for location information
Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Espen Lindholm, ph.d Oslo University Hospital
Tracking Information
First Submitted Date  ICMJE July 9, 2018
First Posted Date  ICMJE August 15, 2018
Last Update Posted Date May 17, 2021
Actual Study Start Date  ICMJE April 2, 2019
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2018)
  • Length of stay at the primary hospital [ Time Frame: 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.
  • Concentration of Lactate (mM), Pyruvate (microM), Glycerol (microM), Glucose (mM) in microdialysate [ Time Frame: 30 days after surgery - postoperative day 30 ]
    Concentration of Lactate, Pyruvate, Glycerol, Glucose in microdialysate in relation to patients with or without anastomosis leakage
  • Concentration of inflammatory markers in microdialysate [ Time Frame: 30 days after surgery - postoperative day 30 ]
    Concentration of inflammatory markers in microdialysate in relation to patients with or without anastomosis leakage
  • Concentration of inflammatory markers in serum [ Time Frame: 30 days after surgery - postoperative day 30 ]
    Concentration of inflammatory markers in serum in relation to patients with or without anastomosis leakage
  • 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 ]
    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
  • 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 ]
    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
  • 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 ]
    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
  • 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 ]
    Subgroup score Pain - Abdominal surgery Impact scale. The summative scores for the scale range from 3 to 18, with higher scores indicating more pain
  • 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 ]
    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
  • 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 ]
    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
  • 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 ]
    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
  • 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 ]
    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
  • Expenses (Euros) per patient used during total hospital stay [ Time Frame: 30 days after surgery - postoperative day 30 ]
    Number of Euros used in patient undergoing pancreaticoduodenectomy With or without microdialysis catheter
  • 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 ]
    Number of catheter which are not functioning
  • 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 ]
    Numbers of risk factors of postoperative pancreatic fistula in relation to patients with or without anastomosis leakage
  • Risk factors of postoperative pancreatic fistula at 30 days after surgery [ Time Frame: 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
  • Risk factors of postoperative pancreatic fistula at 90 days after surgery [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 10, 2018)
  • Time before postoperative fistula is diagnosed (hours) [ Time Frame: End of surgery to 30 days postoperative ]
    Hours from end of surgery to diagnosis of postoperative pancreatic fistula
  • Total quantity (μg/mg) of vasoactive medications at discharge 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 ]
    Amount of vasoactive medication during surgery and postoperatively until discharge from the hospital where the surgery was performed.
  • Number of patients with Pancreatic Fistula [ Time Frame: 30 days after surgery - postoperative day 30 ]
    Number of patients with Pancreatic Fistula
  • Number of patients with Biliary Fistula [ Time Frame: 30 days after surgery - postoperative day 30 ]
    Number of patients with Biliary Fistula
  • Number of patients with gastroenteric Fistula [ Time Frame: 30 days after surgery - postoperative day 30 ]
    Number of patients with gastroenteric Fistula
  • 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 [ Time Frame: 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
  • Postoperative complications [ Time Frame: From inclusion to 90-days after surgery ]
    Number of patients with postoperative complications during total hospital stay
  • Fluid Balance (ml) during hospital admission at an average of 10 days after surgery [ Time Frame: 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
  • Number of patients discharged to home/self care at an average of 10 days after surgery [ Time Frame: At discharge at an average of 10 days after surgery ]
    Patient's discharge disposition - number of patients Discharged to home/self care
  • Number of patients discharged to home but with home health service at an average of 10 days [ Time Frame: 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
  • Number of patients discharged/transferred to nursing home at an average of 10 days [ Time Frame: At discharge at an average of 10 days after surgery ]
    Patient's discharge disposition - number of patients Discharged/transferred to nursing home
  • Number of patients discharged/transferred to an inpatient rehabilitation facility at an average of 10 days [ Time Frame: At discharge at an average of 10 days after surgery ]
    Discharged to an inpatient rehabilitation facility
  • Number of patients expired at an average of 10 days [ Time Frame: At discharge at an average of 10 days after surgery ]
    Patient's discharge disposition - expired
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy
Official Title  ICMJE Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy - a Randomized Controlled Trial. THE MINIMUM STUDY
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
2-armed, multicenter, randomized, open label, parallel-group controlled trial (RCT)
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • Biliary Tract Cancer
  • Duodenal Cancer
  • Pancreatic Fistula
Intervention  ICMJE Procedure: Surgical og radiological intervention, antibiotics
Intervention might be a new drainage catheter, replacement of old drainage catheter, reoperation, somatostatin- and antibiotic administration.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Surgical og radiological intervention, antibiotics
  • 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.
Publications * Lindholm E, Ekiz N, Tønnessen 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 14, 2021)
201
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2018)
200
Estimated Study Completion Date  ICMJE November 1, 2022
Estimated Primary Completion Date August 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03631173
Other Study ID Numbers  ICMJE 2018/1334
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan for individual participant data (IPD).
Responsible Party Espen Lindholm, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Espen Lindholm, ph.d Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院