Early Detection of Anastomotic Leakage by Microdialysis Catheters

University of Oslo (UIO)

Status: Completed

Conditions: Pancreatic Fistula; Pancreas; Fistula; Pancreaticoduodenal; Fistula; Pancreatic Cancer

Treatments: Procedure: Pancreaticoduodenectomy microdialysis catheter analyses

Study type: Observational

Funder types: Other

Identifiers

NCT03627559

2012/143

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 1 patient group

Pancreaticoduodenectomy patients

Description:

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

Treatment:

Procedure: Pancreaticoduodenectomy microdialysis catheter analyses