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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03627559
Other study ID # 2012/143
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2013
Est. completion date July 1, 2018

Study information

Verified date August 2018
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date July 1, 2018
Est. primary completion date March 31, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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