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| Name | Class |
|---|---|
| Senzime AB | INDUSTRY |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microdialysis catheter | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OnZurf Probe | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Johansson, PhD | Region Skane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skånes Universitetssjukhuset | Lund | Skåne County | Sweden |
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| ID | Term |
|---|---|
| D007511 | Ischemia |
| D057868 | Anastomotic Leak |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| 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 |
| 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 |
| 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 |