Back to resultsLocal Metabolism of the Gastric Tube Reconstruction After Esophagectomy
Primary Purpose
Microdialysis, Ischemia, Anastomotic Leakage
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
OnZurf Probe
Sponsored by
About this trial
This is an interventional diagnostic trial for Microdialysis
Eligibility Criteria
Inclusion Criteria:
- All patients accepted for esophagectomy with Gastric Tube reconstruction in the Department
Exclusion Criteria:
- Surgical recontruction other than Gastric Tube
Sites / Locations
- Skånes Universitetssjukhuset
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Microdialysis catheter
Arm Description
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.
Outcomes
Primary Outcome Measures
Concentration of lactate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Concentration in millimoles / liter of lactate measured repeatedly (see below) to produce a metabolic profile over time
Concentration of lactate measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Concentration in millimoles / liter of lactate measured repeatedly (see below) to produce a metabolic profile over time
Concentration of glucose measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Concentration in millimoles / liter of glucose measured repeatedly (see below) to produce a metabolic profile over time
Concentration of glucose measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Concentration in millimoles / liter of glucose measured repeatedly (see below) to produce a metabolic profile over time
Concentration of pyruvate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Concentration in millimoles / liter of pyruvate measured repeatedly (see below) to produce a metabolic profile over time
Concentration of pyruvate measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Concentration in millimoles / liter of pyruvate measured repeatedly (see below) to produce a metabolic profile over time
Concentration of glycerol measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Concentration in millimoles / liter of glycerol measured repeatedly (see below) to produce a metabolic profile over time
Concentration of glycerol measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Concentration in millimoles / liter of glycerol measured repeatedly (see below) to produce a metabolic profile over time
Secondary Outcome Measures
Full Information
NCT ID
NCT04319835
First Posted
March 30, 2016
Last Updated
August 17, 2020
Sponsor
Region Skane
Collaborators
Senzime AB
1. Study Identification
Unique Protocol Identification Number
NCT04319835
Brief Title
Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy
Official Title
Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 25, 2016 (Actual)
Primary Completion Date
March 4, 2019 (Actual)
Study Completion Date
March 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Senzime AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microdialysis, Ischemia, Anastomotic Leakage
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Microdialysis catheter
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
OnZurf Probe
Primary Outcome Measure Information:
Title
Concentration of lactate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Description
Concentration in millimoles / liter of lactate measured repeatedly (see below) to produce a metabolic profile over time
Time Frame
Measured with four hour intervals during the first seven postoperative days
Title
Concentration of lactate measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Description
Concentration in millimoles / liter of lactate measured repeatedly (see below) to produce a metabolic profile over time
Time Frame
Measured with four hour intervals during the first seven postoperative days
Title
Concentration of glucose measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Description
Concentration in millimoles / liter of glucose measured repeatedly (see below) to produce a metabolic profile over time
Time Frame
Measured with four hour intervals during the first seven postoperative days
Title
Concentration of glucose measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Description
Concentration in millimoles / liter of glucose measured repeatedly (see below) to produce a metabolic profile over time
Time Frame
Measured with four hour intervals during the first seven postoperative days
Title
Concentration of pyruvate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Description
Concentration in millimoles / liter of pyruvate measured repeatedly (see below) to produce a metabolic profile over time
Time Frame
Measured with four hour intervals during the first seven postoperative days
Title
Concentration of pyruvate measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Description
Concentration in millimoles / liter of pyruvate measured repeatedly (see below) to produce a metabolic profile over time
Time Frame
Measured with four hour intervals during the first seven postoperative days
Title
Concentration of glycerol measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Description
Concentration in millimoles / liter of glycerol measured repeatedly (see below) to produce a metabolic profile over time
Time Frame
Measured with four hour intervals during the first seven postoperative days
Title
Concentration of glycerol measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Description
Concentration in millimoles / liter of glycerol measured repeatedly (see below) to produce a metabolic profile over time
Time Frame
Measured with four hour intervals during the first seven postoperative days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients accepted for esophagectomy with Gastric Tube reconstruction in the Department
Exclusion Criteria:
Surgical recontruction other than Gastric Tube
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Johansson, PhD
Organizational Affiliation
Region Skane
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skånes Universitetssjukhuset
City
Lund
State/Province
Skåne
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy
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