The Change of NK Cell Activity After Head and Neck Cancer Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02661776

Enrollment

Registered

2016-01-22

Start date

2016-03-24

Completion date

2017-05-04

Last updated

2017-10-02

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

Conditions

The Patients Undergoing Head and Neck Surgery Including Tumor Removal and Reconstruction With Flap

Keywords

natural killer cell, head and neck cancer, opioid

Brief summary

Cellular immunity can be changed after surgery and anesthesia. Tissue injury by surgical procedures significantly reduces the immune function in proportion to the degree of tissue injury. In addition, the use of opioids as analgesics during the perioperative period depress cellular immunity, in particular the activity of the natural killer (NK) cells. This perioperative immunosuppression may cause deleterious consequences on postoperative outcome in cancer patients. The aim of this study is to confirm the presence or extent of the change of NK cell activity between before and after head and neck surgery. Additionally, investigators will identify the clinical or genetic factors related to the change of NK cell activity.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

1\) The patients undergoing head and neck surgery including tumor removal and reconstruction with flap

Exclusion criteria

1. patients refusal 2. patients not able to read, or understand the consent form 3. History of Active viral or bacterial infection 4. History of use of immunosuppressive drugs within the last six months 5. History of chemotherapy 6. History of autoimmune disorders 7. Known HIV, Hepatitis B, or Hepatitis C infection 8. Female who is pregnant, nursing 9. ethnicity, other than asian

Design outcomes

Primary

Measure	Time frame	Description
The change of NK cell activity	24 hours	Preoperative NK cell activity will be measured using the NK vue diagnostic test before surgery and anesthesia. Postoperative NK cell activity will be measured using the NK vue diagnostic test after 24 hours since stopping the use of intravenous remifentanil as analgesics during anesthesia in the operating room or sedation in the intensive care unit.

Countries

South Korea

Outcome results