NCT04319835

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

April 25, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2019

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

2.9 years

First QC Date

March 30, 2016

Last Update Submit

August 17, 2020

Conditions

MicrodialysisIschemiaAnastomotic Leakage

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

Study Arms (1)

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.

Device: OnZurf Probe

Interventions

OnZurf ProbeDEVICE
Microdialysis catheter

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Surgical recontruction other than Gastric Tube

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skånes Universitetssjukhuset

Lund, Skåne County, Sweden

Location

MeSH Terms

Conditions

IschemiaAnastomotic Leak

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Study Officials

  • Jan Johansson, PhD

    Region Skane

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2016

First Posted

March 24, 2020

Study Start

April 25, 2016

Primary Completion

March 4, 2019

Study Completion

March 4, 2019

Last Updated

August 19, 2020

Record last verified: 2020-08

Locations

SE(1)