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2013-10-01
2014-03-31
2018-07-01
35
NCT03627559
Oslo University Hospital
Oslo University Hospital
OBSERVATIONAL
Early Detection of Anastomotic Leakage by Microdialysis Catheters
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-07-09 | N/A | 2018-08-10 |
2018-08-10 | N/A | 2018-08-13 |
2018-08-13 | N/A | 2018-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Glycerol concentration postoperatively | 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 | Measured hourly during the first 24 hours and thereafter every 2-4 hours during hospitalization at an average of 10 days after surgery |
| Glucose concentration postoperatively | 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 | 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 |
| Lactate concentration postoperatively | 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 | 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 |
| Pyruvate concentration postoperatively | 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 | 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
