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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Fistula Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Fistula Neoplasms Neoplasms by Site Pancreas; Fistula Pancreatic Diseases Pancreatic Fistula Pancreatic Neoplasms Pancreaticoduodenal; Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Pancreaticoduodenectomy microdialysis catheter analyses

Procedure

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 outcomes

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
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
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
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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2018
First posted: Aug 13, 2018
Registry last updated: Aug 13, 2018

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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