The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved

November 1, 2017 updated by: Guizhi Du

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

With the increasing number of patients diagnosed with colorectal cancer, the proportion of patients undergoing surgical resection with general anesthesia increased. However, the operation can lead tumor cells releasing into the blood or peritoneal implantation, and the impaired immune response can make patients susceptible to the development of tumor metastasis and recurrence which is the the main reason of death. It is well known that B lymphocytes and T lymphocytes are the main immune cells, and B lymphocytes by secreting antibodies are related to humoral immunity and T lymphocytes which play the most important role in antitumor are related to cell-mediated immunity. Surgery stress leads to metabolic and neuroendocrine changes causing significant depression of immunity. Although general anesthesia could reduce surgical stress, studies indicated general anesthetics including intravenous and inhalational agents both have variable effects on tumor cells growth by immuno-modulation and some cytokines. A number of studies have demonstrated deleterious effects on the function of lymphocytes associated with the administration of volatile inhalational anesthetic agents. It was suggested that the use of volatile inhalational agent may augment tumor cells growth by inhibiting the activity of lymphocytes, NK cells and dendritic cells which are important for recognizing, capturing and killing tumor cells, however, the alternative propofol has a converse (beneficial) effect by decreasing the plasma level of cytokines secreted by activated lymphocytes, macrophages and NK cells. The detailed mechanism of how volatile anesthetics affect the activity of antitumor cells remains unknown. Thus the investigators will conduct the clinical investigation to study the effect of volatile anesthetics on the immune response and metastasis in patients undergoing colorectal cancer resection, exploring molecular mechanism involved if inhalational anesthetics show an effect. The findings of this study would be valuable for anesthetic regimen guidance of colorectal cancer patients undergoing surgical resection in terms of long-term survival.

Study Type

Observational

Enrollment (Anticipated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University, Department of Anesthesiology
        • Contact:
        • Principal Investigator:
          • Guizhi Du, MD, PhD
        • Sub-Investigator:
          • Yan Qiu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with colonal or rectal cancer undergoing cancer resection with general anesthesia

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Total intravenous anesthesia group
The anesthesia of patients in the total intravenous anesthesia group will be maintained with propofol and remifentanil.
Drug: Propofol
Propofol will be used for anesthesia maintenance in the total intravenous anesthesia group.
Other Names:
  • Diprivan
Drug: Remifentanil
Remifentanil will be used for analgesia in both groups.
Other Names:
  • YiChang HumanWell Pharmaceutical Co.，LTD. China
Inhalational anesthesia group
The anesthesia of patients in the inhalational anesthesia group will be maintained with sevoflurane and remifentanil.
Drug: Remifentanil
Remifentanil will be used for analgesia in both groups.
Other Names:
  • YiChang HumanWell Pharmaceutical Co.，LTD. China
Drug: Sevoflurane
Sevoflurane will be used for anesthesia maintenance in the inhalation anesthesia group.
Other Names:
  • Abbvie

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline lymphocytes within postoperative 5 years
Time Frame: up to 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
Time Frame: 5 years or as available
Patients who remain alive without known colonal or rectal tumor recurrence
5 years or as available

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer recurrence rate
Time Frame: up to 5 years
Patients who remain alive with known colonal or rectal tumor recurrence
up to 5 years
Cancer metastasis rate
Time Frame: up to 5 years
Patients who remain alive with known colonal or rectal tumor metastasis
up to 5 years
Re-operation
Time Frame: up to 5 years
Patients who have a surgery under general anesthesia
up to 5 years
Anesthesia scheme for re-operation
Time Frame: up to 5 years
Total intravenous anesthesia, inhalational anesthesia or combined anesthesia
up to 5 years
Radiotherapy rate for any cancer
Time Frame: up to 5 years
Patients have radiotherapy for any cancer
up to 5 years
Chemotherapy rate for any cancer
Time Frame: up to 5 years
Patients have chemotherapy for any cancer
up to 5 years
Circulating tumor cells
Time Frame: up to 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 circulating tumor cells
up to 5 years
Concentration of cytokines
Time Frame: up to 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 IL, TNF-α, IFN-γ and GCSF
up to 5 years
Colorectal cancer antibodies
Time Frame: up to 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 CEA, CA199, GP87 and TPA.
up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-operation during hospitalization
Time Frame: From end of colorectal cancer resection surgery to discharge, up to one month
Patients receive a reoperation for any reason during hospitalization
From end of colorectal cancer resection surgery to discharge, up to one month
Days of hospitalization
Time Frame: From end of colorectal cancer resection surgery to discharge, up to one month
The duration of patients stay in hospital
From end of colorectal cancer resection surgery to discharge, up to one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guizhi Du

Investigators

  • Study Chair: Jin Liu, MD, PhD, Department of Anesthesiology, West China Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 17, 2017

First Posted (Actual)

June 21, 2017

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WestChinaHospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All the study outcomes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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