Skip to main content
OpenTrials
Completed

NCT Number: NCT04319835

Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy

Postoperative surveillance of local metabolism of the surgical reconstruction after esophagectomy by means of Microdialysis. Dialysate is collected continuously for seven postoperative Days. Results analysed in a blinded fashion and related to the clinical outcome. Primary endpoint: anastomotic leakage

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Microdialysis Anastomotic Leak Anastomotic Leakage Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skånes Universitetssjukhuset

Lund, Skåne County, Sweden

About this study

The purpose of the study is to evaluate Onzurf probe (microdialysis probe) as a monitoring method for the early diagnosis of complications after surgery in the gastrointestinal tract. Samples taken with Onzurf probe will be analyzed and then compared with routine clinical data on surgical procedures in gastrointesinala tract. These parameters are: Patient general condition, endoscopy, radiology and routine clinical samples (global) as CRP (C-reactive protein), white blood cells, blood gases.The patients are their own controls when the purpose is to see if you can detect early complications with Onzurf probe and also identify how many people gets complications after surgery in the gastrointestinal tract. The patients' clinical routine tests (blood tests, etc.) will serve as control samples, which then will be compared with results from sampling of Onzurf probe. No interventions will be carried out on the patient.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients accepted for esophagectomy with Gastric Tube reconstruction in the Department

Exclusion criteria

  • Surgical recontruction other than Gastric Tube

Treatment and study plan

OnZurf Probe

Device

Primary outcomes

  1. Concentration of lactate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology

    Time frame: Measured with four hour intervals during the first seven postoperative days

    Concentration in millimoles / liter of lactate measured repeatedly (see below) to produce a metabolic profile over time

  2. Concentration of lactate measured by microdialysis in patients with a normal uncomplicated postoperative recovery

    Time frame: Measured with four hour intervals during the first seven postoperative days

    Concentration in millimoles / liter of lactate measured repeatedly (see below) to produce a metabolic profile over time

  3. Concentration of glucose measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology

    Time frame: Measured with four hour intervals during the first seven postoperative days

    Concentration in millimoles / liter of glucose measured repeatedly (see below) to produce a metabolic profile over time

  4. Concentration of glucose measured by microdialysis in patients with a normal uncomplicated postoperative recovery

    Time frame: Measured with four hour intervals during the first seven postoperative days

    Concentration in millimoles / liter of glucose measured repeatedly (see below) to produce a metabolic profile over time

  5. Concentration of pyruvate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology

    Time frame: Measured with four hour intervals during the first seven postoperative days

    Concentration in millimoles / liter of pyruvate measured repeatedly (see below) to produce a metabolic profile over time

  6. Concentration of pyruvate measured by microdialysis in patients with a normal uncomplicated postoperative recovery

    Time frame: Measured with four hour intervals during the first seven postoperative days

    Concentration in millimoles / liter of pyruvate measured repeatedly (see below) to produce a metabolic profile over time

  7. Concentration of glycerol measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology

    Time frame: Measured with four hour intervals during the first seven postoperative days

    Concentration in millimoles / liter of glycerol measured repeatedly (see below) to produce a metabolic profile over time

  8. Concentration of glycerol measured by microdialysis in patients with a normal uncomplicated postoperative recovery

    Time frame: Measured with four hour intervals during the first seven postoperative days

    Concentration in millimoles / liter of glycerol measured repeatedly (see below) to produce a metabolic profile over time

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Senzime AB

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 24, 2020
Registry last updated
Aug 19, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.