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临床试验/NCT03193710
NCT03193710Unknown不适用

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

Guizhi Du1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2017年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
260
试验地点
1
主要终点
Change from baseline lymphocytes within postoperative 5 years

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Total intravenous anesthesia group

The anesthesia of patients in the total intravenous anesthesia group will be maintained with propofol and remifentanil.

干预措施: Propofol (Drug)

Total intravenous anesthesia group

The anesthesia of patients in the total intravenous anesthesia group will be maintained with propofol and remifentanil.

干预措施: Remifentanil (Drug)

Inhalational anesthesia group

The anesthesia of patients in the inhalational anesthesia group will be maintained with sevoflurane and remifentanil.

干预措施: Sevoflurane (Drug)

Inhalational anesthesia group

The anesthesia of patients in the inhalational anesthesia group will be maintained with sevoflurane and remifentanil.

干预措施: Remifentanil (Drug)

结局指标

主要结局

Change from baseline lymphocytes within postoperative 5 years

时间窗: 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

Cancer free survival

时间窗: 5 years or as available

Patients who remain alive without known colonal or rectal tumor recurrence

次要结局

  • Cancer metastasis rate(up to 5 years)
  • Anesthesia scheme for re-operation(up to 5 years)
  • Cancer recurrence rate(up to 5 years)
  • Chemotherapy rate for any cancer(up to 5 years)
  • Colorectal cancer antibodies(up to 5 years)
  • Re-operation(up to 5 years)
  • Radiotherapy rate for any cancer(up to 5 years)
  • Circulating tumor cells(up to 5 years)
  • Concentration of cytokines(up to 5 years)

研究者

发起方
Guizhi Du
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Guizhi Du

Associate Professor

West China Hospital

研究点 (1)

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