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

Completed

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

• Registration Number: NCT02661776
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-22
• Study Start: 2016-03-24
• Primary Completion: 2017-05-04
• Study Completion: 2017-05-04
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-27
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine; 🇰🇷 Seoul, Korea, Republic of