Early Detection of Anastomotic Leakage by Microdialysis Catheters

Pancreatic Cancer Clinical Trial

Official title:

Early Detection of Anastomotic Leakage by Microdialysis Catheters: An Observational Study on Pancreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627559
• Other study ID #: 2012/143
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Anastomotic Leak
• Fistula
• Pancreas; Fistula
• Pancreatic Cancer
• Pancreatic Fistula
• Pancreatic Neoplasms
• Pancreaticoduodenal; Fistula

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