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Early Detection of Anastomotic Leakage by Microdialysis Catheters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627559
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Espen Lindholm, Oslo University Hospital

Brief Summary:
Anastomotic leakage of the pancreatojejunostomy is often discovered with considerable delay, causing severe peritonitis, hemorrhage due to erosion of vessels, sepsis, and death. Microdialysis catheters can detect focal inflammation and ischemia, and has a potential for early detection of anastomotic leakage. This observational study will examine if monitoring with microdialysis catheters can detect anastomotic leakage after pancreaticoduodenectomy earlier than current standard of care.

Condition or disease Intervention/treatment
Pancreatic Cancer Pancreaticoduodenal; Fistula Pancreas; Fistula Pancreatic Fistula Procedure: Pancreaticoduodenectomy microdialysis catheter analyses

Detailed Description:

Pancreaticoduodenectomy (Whipple´s procedure) offers the only potential cure for patients with tumor in the head of the pancreas, bile duct or periampullary region. This procedure is associated with high perioperative and postoperative mortality and morbidity. Postoperative pancreatic fistulae (POPF) is the most feared complication, and is often discovered with significant delay resulting in development of organ dysfunction and sepsis. Current standard for clinical detection of POPF is limited and nonspecific.

Microdialysis catheters allow bedside measurements of metabolism such as lactate, pyruvate, glucose and glycerol. The method has a high sensitivity and specificity in detecting complications in several types of abdominal surgery. However, microdialysis used after pancreaticoduodenectomy is not well documented. This observational study examine if monitoring with microdialysis catheters can detect anastomotic leakage after pancreaticoduodenectomy earlier than current standard of care.

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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection of Anastomotic Leakage by Microdialysis Catheters: An Observational Study on Pancreaticoduodenectomy
Actual Study Start Date : October 1, 2013
Actual Primary Completion Date : March 31, 2014
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pancreaticoduodenectomy patients
All patients undergoing pancreaticoduodenectomy receive a microdialysis catheter before skin closure and will be monitored postoperatively for lactate, pyruvate, glucose and glycerol in the microdialysate at certain timepoints
Procedure: Pancreaticoduodenectomy microdialysis catheter analyses
A thin microdialysis catheter is implanted before skin closure after pancreaticoduodenectomy. Analyses of the microdialysate are done at certain timepoints postoperatively. No intervention is done based on the results. The patients are following standard of care.




Primary Outcome Measures :
  1. Glycerol concentration postoperatively [ Time Frame: Measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery ]
    Glycerol concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery

  2. Glucose concentration postoperatively [ Time Frame: Measured hourly after surgery during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery ]
    Glucose concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery

  3. Lactate concentration postoperatively [ Time Frame: Measured hourly after surgery during the first 24 hours after surgery and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery ]
    Lactate concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery

  4. Pyruvate concentration postoperatively [ Time Frame: Measured hourly after surgery during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery ]
    Pyruvate concentration of the microdialysate is measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery


Biospecimen Retention:   Samples Without DNA
Microdialysate


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Both genders from age 18 and older. Tumor in the head of the pancreas, the bile duct or the duodenum. Planned to undergo pancreaticoduodencetomy
Criteria

Inclusion Criteria:

  • Tumor in the head of the pancreas, the bile duct or the duodenum detected on a computed tomography (CT) scan or magnetic resonance imaging (MRI), and evaluated by a multidisciplinary team to be resectable with a pancreaticoduodenectomy.
  • Written informed consent was obtained before study enrollment.

Exclusion Criteria:

  • <18 years
  • patient with tumor which was not resectable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627559


Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Espen Lindholm, ph.d Oslo University Hospital
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Responsible Party: Espen Lindholm, senior Researcher, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03627559    
Other Study ID Numbers: 2012/143
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan for share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Espen Lindholm, Oslo University Hospital:
Pancreaticoduodenectomy
Pancreatectomy
Additional relevant MeSH terms:
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Pancreatic Fistula
Fistula
Anastomotic Leak
Digestive System Diseases
Pancreatic Diseases
Pathological Conditions, Anatomical
Digestive System Fistula
Postoperative Complications
Pathologic Processes