Clinical trial NCT04319835: Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy
Official title: Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microdialysis
Ischemia
Anastomotic Leakage
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Senzime AB
First posted: 2020-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Surgical recontruction other than Gastric Tube

Primary outcomes:
measure: Concentration of lactate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
timeFrame: Measured with four hour intervals during the first seven postoperative days
measure: Concentration of lactate measured by microdialysis in patients with a normal uncomplicated postoperative recovery
timeFrame: Measured with four hour intervals during the first seven postoperative days
measure: Concentration of glucose measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
timeFrame: Measured with four hour intervals during the first seven postoperative days
measure: Concentration of glucose measured by microdialysis in patients with a normal uncomplicated postoperative recovery
timeFrame: Measured with four hour intervals during the first seven postoperative days
measure: Concentration of pyruvate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
timeFrame: Measured with four hour intervals during the first seven postoperative days
measure: Concentration of pyruvate measured by microdialysis in patients with a normal uncomplicated postoperative recovery
timeFrame: Measured with four hour intervals during the first seven postoperative days
measure: Concentration of glycerol measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
timeFrame: Measured with four hour intervals during the first seven postoperative days
measure: Concentration of glycerol measured by microdialysis in patients with a normal uncomplicated postoperative recovery
timeFrame: Measured with four hour intervals during the first seven postoperative days
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skånes Universitetssjukhuset
state: Skåne
Study officials:
affiliation: Region Skane
name: Jan Johansson, PhD
role: PRINCIPAL_INVESTIGATOR
References: