Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04319835

Enrollment

Registered

2020-03-24

Start date

2016-04-25

Completion date

2019-03-04

Last updated

2020-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leakage, Ischemia, Microdialysis

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.

Interventions

DEVICEOnZurf Probe

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Surgical recontruction other than Gastric Tube

Design outcomes

Primary

Measure	Time frame	Description
Concentration of lactate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology	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
Concentration of lactate measured by microdialysis in patients with a normal uncomplicated postoperative recovery	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
Concentration of glucose measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology	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
Concentration of glucose measured by microdialysis in patients with a normal uncomplicated postoperative recovery	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
Concentration of pyruvate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology	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
Concentration of pyruvate measured by microdialysis in patients with a normal uncomplicated postoperative recovery	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
Concentration of glycerol measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology	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
Concentration of glycerol measured by microdialysis in patients with a normal uncomplicated postoperative recovery	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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026