Assessment of the Anesthetic Effect on the Activity of Im... | NCT02567942

Studies
Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Colon Cancer

NCT02567942

Sponsor

Konkuk University Medical Center

Status

Completed

Last Update Posted

Apr 20, 2021Actual

Enrollment

153Actual

Phase

Not Applicable

Conditions

Colon Cancer

Interventions

propofol group
sevoflurane group

Countries

South Korea

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

Apr 2021

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

Feb 2016Actual

Primary Completion Date

Apr 2018Actual

Completion Date

Apr 2018Actual

First Submitted Date

Sep 2, 2015

First Submission Date that Met QC Criteria

Oct 1, 2015

First Posted Date

Oct 5, 2015Estimated

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

Apr 17, 2021

Last Update Posted Date

Apr 20, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seong-Hyop Kim, Associate Professor, Konkuk University Medical CenterPrincipal Investigator

Lead Sponsor

Konkuk University Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Anesthetics agents has variety inflammation during the cancer surgery. This perioperative inflammation can influence to cancer metastasis or recurrence.

The purpose of this study is to prove the variation of immune cell activity between preoperative and postoperative period.

Detailed Description

The patients were allocated randomly to receive propofol or sevoflurane. Also, a total of 18ml of blood sample was obtained for total 3 times in consecutive order.

immediate before anesthesia induction
postoperative 1 hours
postoperative 24 hours

Serum in blood will be obtained and activity of helper T cell, natural killer cell and level of serum cytokine will be evaluated by flow cytometry or enzyme-linked immunosorbent assay

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

153Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
propofol group	Other	The patient who anesthetized by using propofol.	Drug: propofol group
sevoflurane group	Other	The patient who anesthetized by using propofol.	Drug: sevoflurane group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
propofol group	Drug	Patient will be anesthetized by using propofol infusion during operation	propofol group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
natural killer cell activity	change of percentage of natural killer cell (scores range from 0 to 100)	preoperative time. postoperative 1 hours and 24 hours

Secondary Outcomes

Measure	Description	Time Frame
helper T cell activity	change of percentage of helper T cell (scores range from 0 to 100)	preoperative time. postoperative 1 hours and 24 hours

Other Outcomes

Measure	Description	Time Frame
change of percentage of CD39 and CD73	change of percentage of CD39 and CD73 (scores range from 0 to 100)	preoperative time. postoperative 1 hours and 24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient who was planned to undergo colon cancer surgery.

Exclusion Criteria:

age < 20 years old
history of hypersensitivity reaction in propofol or sevoflurane
history of previous cancer
patient with ongoing inflammation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seong-Hyop Kim, M.D,Ph.D	Konkuk University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Konkuk University Medical Center		Seoul		143-729	South Korea

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

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol
D000077149	Sevoflurane

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided