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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04319835
Other study ID # U-1506
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 25, 2016
Est. completion date March 4, 2019

Study information

Verified date August 2020
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 4, 2019
Est. primary completion date March 4, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Surgical recontruction other than Gastric Tube

Study Design


Intervention

Device:
OnZurf Probe


Locations

Country Name City State
Sweden Skånes Universitetssjukhuset Lund Skåne

Sponsors (2)

Lead Sponsor Collaborator
Region Skane Senzime AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Measured with four hour intervals during the first seven postoperative days
Primary 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 Measured with four hour intervals during the first seven postoperative days
Primary 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 Measured with four hour intervals during the first seven postoperative days
Primary 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 Measured with four hour intervals during the first seven postoperative days
Primary 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 Measured with four hour intervals during the first seven postoperative days
Primary 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 Measured with four hour intervals during the first seven postoperative days
Primary 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 Measured with four hour intervals during the first seven postoperative days
Primary 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 Measured with four hour intervals during the first seven postoperative days
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