跳至主要内容
临床试验/NCT04518579
NCT04518579已完成不适用

Effect of Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients Undergoing Open Surgery for Cancer Colon

South Egypt Cancer Institute2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
anti tumour immunity

研究概览

简要总结

Surgery is the primary treatment for colon cancer. However, the rate of recurrence or metastasis in colon cancer can be as high as 30%, even in stages 1 and 2 . Most colon cancer-related deaths are caused by metastatic disease . Many patients with colon cancer harbour micrometastases and disseminated tumour cells at the time of surgery . Whether the micrometastases develop into clinically significant metastases depends on the immune system's ability to eradicate them.The aim of the study is to declare the effect of epidural-intravenous based anesthetic technique on anti-tumor immunity and in comparison to epidural inhalational based anesthetic technique in patients undergoing open surgical resection of colon cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-70 yrs.
  • ASA class I and II
  • Elective open surgery for non-metastatic cancer colon stage I,II

排除标准

  • Patient refusal
  • Known allergy to the study medications
  • Patients with compromised immune function ( associated blood diseases, immunosuppressive drugs, chemotherapeutic agents, corticosteroids)
  • Contraindications to epidural insertion e.g. infection at insertion site and coagulopathy

结局指标

主要结局

anti tumour immunity

时间窗: preoperative and Day 1 postoperatively

Venous blood samples are withdrawn. Samples for measurement of percentage of expression of CD8,CD16 and CD56 will be collected in sodium heparin anticoagulant tubes and will be processed according to manufacturer's instructions,and samples for VEGF-C will be centrifuged at 4000 g. Thereafter, the serum will be stored at -22 C for future measurement

次要结局

  • change in pain intensity(24 hours postoperative)

研究者

发起方
South Egypt Cancer Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bahaa Gamal

Assistant lecturer

South Egypt Cancer Institute

研究点 (2)

Loading locations...

相似试验