Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy

August 17, 2020 updated by: Region Skane
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne
      • Lund, Skåne, Sweden
        • Skånes Universitetssjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Surgical recontruction other than Gastric Tube

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Microdialysis catheter
Surface Microdialysis catheter will be placed onto the surgical reconstruction after esophagectomy and will be evaluated for clinical safety and performance. The metabolic profile as measured by Microdialysis will be correlated to the clinical outcome. No interventions based on the results will be performed.
Device: OnZurf Probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured with four hour intervals during the first seven postoperative days
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
Measured with four hour intervals during the first seven postoperative days
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
Measured with four hour intervals during the first seven postoperative days
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
Measured with four hour intervals during the first seven postoperative days
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
Measured with four hour intervals during the first seven postoperative days
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
Measured with four hour intervals during the first seven postoperative days
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
Measured with four hour intervals during the first seven postoperative days
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
Measured with four hour intervals during the first seven postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Collaborators

Senzime AB

Investigators

  • Principal Investigator: Jan Johansson, PhD, Region Skane

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 25, 2016

Primary Completion (ACTUAL)

March 4, 2019

Study Completion (ACTUAL)

March 4, 2019

Study Registration Dates

First Submitted

March 30, 2016

First Submitted That Met QC Criteria

March 20, 2020

First Posted (ACTUAL)

March 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 19, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U-1506

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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