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Active, Not Recruiting

NCT Number: NCT03631173

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pancreatic Cancer Biliary Tract Cancer Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Fistula Digestive System Neoplasms Duodenal Cancer Duodenal Diseases Duodenal Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fistula Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Fistula Pancreatic Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical og radiological intervention, antibiotics

Procedure

Intervention might be a new drainage catheter, replacement of old drainage catheter, reoperation, somatostatin- and antibiotic administration.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Monitoring of patIents With Microdialysis Following Pancreaticoduodenectomy - a Randomized Controlled Trial. THE MINIMUM STUDY

Acronym: MINIMUM

Important dates

Study start
2019
Primary completion
2021
Study completion
2028
First posted
Aug 15, 2018
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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