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临床试验/NCT04657237
NCT04657237Unknown不适用

Effect of Anesthesia and Surgical Stress on the Expression of Programmed Death-1 and Programmed Death-1 Ligand on T Lymphocyte After Breast Cancer Surgeries

Assiut University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
change in level of PD1 and PD1 ligand postoperatively

研究概览

简要总结

Surgery is first-line treatment for solid tumors. However, surgical trauma-induced physiologic stress has been demonstrated to facilitate metastasis and recurrence in different types of cancer. It has been reported that the PD-1/PD-L1 pathway could be activated by surgical stress. Hence, we instigate the effect of anesthetic technique on expression of PD1 and PD1 ligand.

详细描述

The cellular immune response plays a central part in postoperative clearance of tumor cells. T lymphocytes and natural killer (NK) cells are two predominant cytotoxic effector cells that are the major components of antitumor immunity. In mouse models, proliferation of T lymphocytes in response to surgical trauma is defective . Programmed death-1 (PD-1) belongs to the CD28 receptor superfamily. It is an inhibitory receptor, and its expression is upregulated on activated leukocytes, resulting in an inhibited immune response. PD-1 interacts with two ligands: programmed death ligand-1 (PD-L1, also referred to as B7-H1) and programmed death ligand-2 (PD-L2, also known as B7-DC). PD-L2 is expressed mainly on activated dendritic cells (DCs) and macrophages, whereas PD-L1 is distributed widely. In addition to immune cells, some subsets of tumor cells also express PD-L1 to escape from immunosurveillance. It has been reported that the PD-1/PD-L1 pathway could be activated by surgical stress. Hence, we instigate the effect of anesthetic technique on expression of PD1 and PD1 ligand.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • patients scheduled for breast cancer surgery

排除标准

  • compromised immune function (such as infection with the human immunodeficiency virus, immunodeficiency, or treatment with corticosteroids, immunosuppressive drugs, or chemotherapy)
  • ASA > III
  • age> 70 years old.
  • patients refusal to the procedure.
  • Infection of the skin at or near site of needle puncture.
  • Coagulopathy .
  • Drug hypersensitivity or allergy to the studied drugs.
  • Central or peripheral neuropthy .
  • Pre-operative opoid consumption ( within 24 hours preoperative )
  • Anomalies of the vertebral column .

结局指标

主要结局

change in level of PD1 and PD1 ligand postoperatively

时间窗: preoerative (day-0),1st day, and 3 rd day after surgery

blood sample will be withdrawn and human peripheral blood monocyte cells (PBMCs) will be separated with a Ficoll-Isopaque density gradient. Flow cytometric analyses will be carried out immediately. For ex vivo experiments, PBMCs will be cultured with Iscove's modified Dulbecco's medium (IMDM) containing 10 % human serum albumin.

次要结局

  • total request of analgesia(24 hours postoperative)

研究者

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

Shereen Mamdouh

Lecturer of anesthesia, ICU and pain managment

Assiut University

研究点 (2)

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