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临床试验/NCT04510935
NCT04510935已完成不适用

Effects of Serum From Hepatocellular Carcinoma Surgery Patients Under Different Anesthetic Methods on Hepatic Cancer Cell Function in Vitro

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2020年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
mean percentage change from post- to pre-operative values of invasion of HepG2 cells cultured in patients' serum

研究概览

简要总结

Numerous studies find that anesthetic methods may influence the recurrence of tumor and the overall survival of patients after primary cancer surgery. Radiofrequency (RF) ablation is now widely used in the clinic for treatment of hepatocellular carcinoma (HCC). Currently, diverse anesthetic methods, including general anesthesia (GA), epidural anesthesia and local anesthesia (LA), are used for RF ablation surgery. Using serum from HCC surgery patients randomized to receive either GA or LA during surgery, we will investigate the effects of anesthetic methods on cellular invasion, migration and proliferation of HepG2 hepatic cancer cells in vitro. The expression levels of inflammatory cytokines in the serum from patients of both groups will also be analyzed.

详细描述

Patients diagnosed with hepatocellular carcinoma (HCC) undergoing elective radiofrequency (RF) ablation surgery will be randomly allocated to general anesthesia(GA) group or local anesthesia(LA) group.

Patients from GA group will receive anesthesia induced with 0.05-0.1mg/kg intravenous midazolam, 3-6ug/kg fentanyl, 1.0-2.5mg/kg propofol and 0.1-0.2mg/kg atracurium. Laryngeal mask will be used to maintain ventilation. Anesthesia will be maintained with 4-8mg/kg/h propofol and 0.1-0.3ug/kg/min remifentanil, and additional non-depolarizing muscle relaxant when necessary. In patients from LA group, analgesia will be provided by a subcutaneous injection of 2% lidocaine by the surgeons before insertion of the needles.

Serum will be collected from patients of both groups at before induction and 1h post-surgery. The HepG2 hepatic cancer cell line will be treated with patient serum from both groups. The effects of anesthetic methods on cellular invasion, migration, proliferation will be measured. The expression levels of inflammatory cytokines in the serum from patients of both groups will also be analyzed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • 18 to 65 years old
  • ASA grade I-III
  • Diagnosed with a single primary liver tumor of 3cm or smaller
  • Is scheduled for elective radiofrequency ablation surgery
  • With no macro-vascular invasion, no lymph node or extrahepatic metastases
  • Child-Pugh Class A or B

排除标准

  • a history of liver surgery previously (including radiofrequency ablation)
  • severe systemic disease (heart, lung, kidney, or immune system)
  • INR>1.5 or platelet count <45,000 cells/mm3
  • a history of addiction to opioids;
  • Disagree to participate the trial

结局指标

主要结局

mean percentage change from post- to pre-operative values of invasion of HepG2 cells cultured in patients' serum

时间窗: at 1 hour post-surgery

HepG2 cells will be cultured with serum from patients undergoing RF ablation under GA or LA for 24h. Cell invasion will be measured with Matrigel methods. Mean percentage change from post- to pre-operative values of invasion for each individual patient will be calculated and compared between the GA and LA groups.

次要结局

  • serum IL-1β level(at 1 hour post-surgery)
  • serum IL-6 level(at 1 hour post-surgery)
  • serum TNF-α level(at 1 hour post-surgery)
  • mean percentage change from post- to pre-operative values of migration of HepG2 cells cultured in patients' serum(at 1 hour post-surgery)
  • mean percentage change from post- to pre-operative values of proliferation of HepG2 cells cultured in patients' serum(at 1 hour post-surgery)
  • serum IFN-gamma level(at 1 hour post-surgery)
  • serum IL-2 level(at 1 hour post-surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jie Tian

Principle Investigator

RenJi Hospital

研究点 (1)

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