The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved
Comparison of the Effects of Total Intravenous Anesthesia and Inhalation Anesthesia on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and the Mechanism Involved: a Single-center, Randomized, Prospective Study
1 other identifier
observational
260
1 country
1
Brief Summary
The body immunity is important to the development of tumor. The immune system is in charge of monitoring and cleaning tumor cells in circulation. Anesthesia may alter the immune response and affect the elimination of tumor cells. The purpose of the trial is to test whether inhalational anesthetic is relevant to tumor metastasis and recurrence of patients undergoing colorectal cancer resection through depression of lymphocytes-mediated immunity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2017
CompletedFirst Posted
Study publicly available on registry
June 21, 2017
CompletedStudy Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedNovember 6, 2017
June 1, 2017
1.1 years
June 12, 2017
November 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline lymphocytes within postoperative 5 years
Blood will be drawn preoperatively ( at least 24 hours before surgery), prior to anesthesia induction, immediately postoperatively, 24 hours postoperatively, and at postoperative appointments for testing CD4+/CD8+, B lymphocytes, dendritic cells, natural killer cells
up to 5 years
Cancer free survival
Patients who remain alive without known colonal or rectal tumor recurrence
5 years or as available
Secondary Outcomes (9)
Cancer recurrence rate
up to 5 years
Cancer metastasis rate
up to 5 years
Re-operation
up to 5 years
Anesthesia scheme for re-operation
up to 5 years
Radiotherapy rate for any cancer
up to 5 years
- +4 more secondary outcomes
Other Outcomes (2)
Re-operation during hospitalization
From end of colorectal cancer resection surgery to discharge, up to one month
Days of hospitalization
From end of colorectal cancer resection surgery to discharge, up to one month
Study Arms (2)
Total intravenous anesthesia group
The anesthesia of patients in the total intravenous anesthesia group will be maintained with propofol and remifentanil.
Inhalational anesthesia group
The anesthesia of patients in the inhalational anesthesia group will be maintained with sevoflurane and remifentanil.
Interventions
Propofol will be used for anesthesia maintenance in the total intravenous anesthesia group.
Sevoflurane will be used for anesthesia maintenance in the inhalation anesthesia group.
Remifentanil will be used for analgesia in both groups.
Eligibility Criteria
Patients with colonal or rectal cancer undergoing cancer resection with general anesthesia
You may qualify if:
- All the patients diagnosed with colonal or rectal cancer
- Aged 18-65
- ASA I-III
- Assigned to receive resection surgery under general anesthesia, with an expected duration of 2 hours or more
- Agree to participate and give signed written informed consent.
You may not qualify if:
- Severe organic heart, liver and kidney diseases
- Diabetes or hemopoietic disorders
- Allergy to general anesthetics
- Family historical malignant hyperthermia
- Cognition dysfunction
- End-stage cancer or with over 2 cancer metastasis, pathological results were benign tumor or TNM stage was over T1- 3N0 - 2M0
- Other primary malignant tumor
- Immune deficiency or dysfunction or autoimmune disease or long-term usage of corticoids or immunosuppressants
- Receiving general anesthesia within the last 3 months before the resection surgery
- Perioperative transfusion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guizhi Dulead
Study Sites (1)
West China Hospital of Sichuan University, Department of Anesthesiology
Chengdu, Sichuan, 610041, China
Related Publications (10)
Sofra M, Fei PC, Fabrizi L, Marcelli ME, Claroni C, Gallucci M, Ensoli F, Forastiere E. Immunomodulatory effects of total intravenous and balanced inhalation anesthesia in patients with bladder cancer undergoing elective radical cystectomy: preliminary results. J Exp Clin Cancer Res. 2013 Feb 3;32(1):6. doi: 10.1186/1756-9966-32-6.
PMID: 23374147BACKGROUNDQiao Y, Feng H, Zhao T, Yan H, Zhang H, Zhao X. Postoperative cognitive dysfunction after inhalational anesthesia in elderly patients undergoing major surgery: the influence of anesthetic technique, cerebral injury and systemic inflammation. BMC Anesthesiol. 2015 Oct 23;15:154. doi: 10.1186/s12871-015-0130-9.
PMID: 26497059BACKGROUNDMoller Petrun A, Kamenik M. Bispectral index-guided induction of general anaesthesia in patients undergoing major abdominal surgery using propofol or etomidate: a double-blind, randomized, clinical trial. Br J Anaesth. 2013 Mar;110(3):388-96. doi: 10.1093/bja/aes416. Epub 2012 Nov 19.
PMID: 23166149BACKGROUNDJaura AI, Flood G, Gallagher HC, Buggy DJ. Differential effects of serum from patients administered distinct anaesthetic techniques on apoptosis in breast cancer cells in vitro: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i63-7. doi: 10.1093/bja/aet581. Epub 2014 Jul 9.
PMID: 25009197BACKGROUNDBuckley A, McQuaid S, Johnson P, Buggy DJ. Effect of anaesthetic technique on the natural killer cell anti-tumour activity of serum from women undergoing breast cancer surgery: a pilot study. Br J Anaesth. 2014 Jul;113 Suppl 1:i56-62. doi: 10.1093/bja/aeu200. Epub 2014 Jul 9.
PMID: 25009196BACKGROUNDWigmore TJ, Mohammed K, Jhanji S. Long-term Survival for Patients Undergoing Volatile versus IV Anesthesia for Cancer Surgery: A Retrospective Analysis. Anesthesiology. 2016 Jan;124(1):69-79. doi: 10.1097/ALN.0000000000000936.
PMID: 26556730BACKGROUNDWoo JH, Baik HJ, Kim CH, Chung RK, Kim DY, Lee GY, Chun EH. Effect of Propofol and Desflurane on Immune Cell Populations in Breast Cancer Patients: A Randomized Trial. J Korean Med Sci. 2015 Oct;30(10):1503-8. doi: 10.3346/jkms.2015.30.10.1503. Epub 2015 Sep 12.
PMID: 26425050BACKGROUNDBayliss DA, Barrett PQ. Emerging roles for two-pore-domain potassium channels and their potential therapeutic impact. Trends Pharmacol Sci. 2008 Nov;29(11):566-75. doi: 10.1016/j.tips.2008.07.013. Epub 2008 Sep 25.
PMID: 18823665BACKGROUNDPei L, Tan G, Wang L, Guo W, Xiao B, Gao X, Wang L, Li H, Xu Z, Zhang X, Zhao J, Yi J, Huang Y. Comparison of combined general-epidural anesthesia with general anesthesia effects on survival and cancer recurrence: a meta-analysis of retrospective and prospective studies. PLoS One. 2014 Dec 30;9(12):e114667. doi: 10.1371/journal.pone.0114667. eCollection 2014.
PMID: 25548913BACKGROUNDShi C, Thum C, Zhang Q, Tu W, Pelaz B, Parak WJ, Zhang Y, Schneider M. Inhibition of the cancer-associated TASK 3 channels by magnetically induced thermal release of Tetrandrine from a polymeric drug carrier. J Control Release. 2016 Sep 10;237:50-60. doi: 10.1016/j.jconrel.2016.06.044. Epub 2016 Jul 1.
PMID: 27374629BACKGROUND
Biospecimen
Blood of the enrolled patients will be sampled at different time-points for examination of lymphocytes.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jin Liu, MD, PhD
Department of Anesthesiology, West China Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 12, 2017
First Posted
June 21, 2017
Study Start
September 1, 2017
Primary Completion
October 1, 2018
Study Completion
October 1, 2023
Last Updated
November 6, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share
All the study outcomes