Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy

Ischemia Clinical Trial

Official title:

Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319835
• Other study ID #: U-1506
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leakage
• Ischemia
• Microdialysis

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