Early Detection of Anastomotic Leakage by Microdialysis Catheters

NCT03627559 | Completed

• 1 other identifier: 2012/143
• Study Type: observational
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pancreatic Cancer; Pancreaticoduodenal; Fistula; Pancreas; Fistula; Pancreatic Fistula

Keywords

Pancreaticoduodenectomy; Pancreatectomy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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

Interventions

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.

Pancreaticoduodenectomy patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Both genders from age 18 and older. Tumor in the head of the pancreas, the bile duct or the duodenum. Planned to undergo pancreaticoduodencetomy

You may qualify if:

• 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.

You may not qualify if:

• \<18 years
• patient with tumor which was not resectable

Sponsors & Collaborators

• Oslo University Hospital: lead

Related Publications (1)

• Lindholm E, Bergmann GB, Haugaa H, Labori KJ, Yaqub S, Bjornbeth BA, Line PD, Grindheim G, Kjosen G, Pischke SE, Tonnessen TI. Early detection of anastomotic leakage after pancreatoduodenectomy with microdialysis catheters: an observational Study. HPB (Oxford). 2022 Jun;24(6):901-909. doi: 10.1016/j.hpb.2021.10.020. Epub 2021 Nov 5.

  PMID: 34836755 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microdialysate

MeSH Terms

Conditions

Pancreatic Neoplasms; Fistula; Pancreatic Fistula

Condition Hierarchy (Ancestors)

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

Study Officials

• Espen Lindholm, ph.d

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior Researcher

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 13, 2018
• Study Start: October 1, 2013
• Primary Completion: March 31, 2014
• Study Completion: July 1, 2018
• Last Updated: August 13, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share