Evaluation of the Circulatory Status of Stomach Tube and... | NCT03724162

Studies
Evaluation of the Circulatory Status of Stomach Tube and Gastrooesophageal Anastomosis

NCT03724162

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Oct 6, 2020Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Circulatory; Change
Microcirculation

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2018Actual

Primary Completion Date

Oct 1, 2020Actual

Completion Date

Oct 1, 2020Actual

First Submitted Date

Jul 26, 2018

First Submission Date that Met QC Criteria

Oct 26, 2018

First Posted Date

Oct 30, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 4, 2020

Last Update Posted Date

Oct 6, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Syed Sajid Hussain Kazmi, Consultat Vascular Surgeon, Oslo University HospitalPrincipal Investigator

Lead Sponsor

Oslo University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The incidence of anastomotic leaks after gastroesophageal anastomosis after thoracolaparoscopic cancer esophagus surgery is high at the Oslo University Hospital. The patients selected for operation shall be investigated for microcirculatory changes at the thoracic anastomosis site and followed up for any post operative anastomotic leaks.

Detailed Description

- Microcirculation shall be evaluated during the operation with trans serosal laser doppler flowmetry and visible light spectroscopy (LDFVLS). Different anatomical areas of the stomach and gastric tube shall be examined With LDFVLS to find any changes in SO2, rHb, flow, and velocity. Repeat measurements shall be taken to compare them with the baseline measurements.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Impact of local microcirculatory changes on the thoracooesophegial anastomosis after cancer oesophagus surgery	Repeated measurements of microcirculation With laser dopper flometer and visible light spectrometry shall be performed trans serosally of the stoach and gastric tube to register changes in microcirculation. Patients shall be followed up for anastomotic leaks. Besides CT angiography shall be performed before surgery.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with oesophageal carcinoma planned to have thoracolaparoscopic operation and thoracic gastroesophageal anastomosis shall be included.

Exclusion Criteria: Patients who do not give written consent will not be included.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Only subjects selected for thoracolaparoscopic operation shall be included in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oslo University Hospital		Oslo		0424	Norway
Department of vascular surgery, Oslo University Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided