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Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319835
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Senzime AB
Information provided by (Responsible Party):
Region Skane

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

Condition or disease Intervention/treatment Phase
Microdialysis Ischemia Anastomotic Leakage Device: OnZurf Probe Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy
Actual Study Start Date : April 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Surgical recontruction other than Gastric Tube

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319835


Contacts
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Contact: Oscar DM Åkesson, MD oscar.akesson@skane.se
Contact: Sara Vazda, MSc 0737712395 sara.vazda@senzime.com

Locations
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Sweden
Skånes Universitetssjukhuset Recruiting
Lund, Skåne, Sweden
Contact: Oscar Åkesson, MD         
Sponsors and Collaborators
Region Skane
Senzime AB
Investigators
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Principal Investigator: Jan Johansson, PhD Region Skane
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT04319835    
Other Study ID Numbers: U-1506
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemia
Anastomotic Leak
Pathologic Processes
Postoperative Complications