The Neuroendocrine, Metabolic, Inflammatory and Immune Responses to Routine Head and Neck Surgery. An Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The maximum increase (from baseline to day 3 post-op) in cortisol, IL1 and IL6 will be calculated together with their standard deviations.
研究概览
简要总结
The main objective of this pilot study is to observe and document the range of changes in the blood concentrations of certain hormones, inflammatory chemicals and immune chemicals in response to the stimulus of Head and Neck cancer
详细描述
This project is in keeping with the strategy of the anaesthetic and intensive care departments to push towards greater understanding of the immune, metabolic and inflammatory changes associated with surgery and how these may be modified through use of different anaesthetic and intensive care techniques. Through increased understanding of the stress, inflammatory and immune responses to surgery we may be able to modulate peri-operative care to reduce cytotoxic(Natural Killer and Cytotoxic T cell) immunosuppression and hence micrometastatic spread at the time of surgery in future studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective unilateral neck dissections (Levels I-V) and/or Hemithyroidectomy surgery.
- •Royal Marsden Hospital patients with head and neck cancer - all histological sub-types.
- •Capable of providing informed consent
- •American Society of Anaesthesiologists Classification I-III.
排除标准
- •Past history of ipsilateral neck dissection.
- •Bilateral neck dissection
- •A recent course of systemic steroids (< 3 months)
- •Pregnancy
- •Involvement in drug trials
- •On following medications: Interleukins, Interferons, Immunosuppressants and long term opiates
- •Recent Synacthen Test (within 48 hours)
- •Emergency surgery
- •American Society of Anaesthesiologists Classification IV-V.
结局指标
主要结局
The maximum increase (from baseline to day 3 post-op) in cortisol, IL1 and IL6 will be calculated together with their standard deviations.
次要结局
- Description of other blood parameters related to stress response.
- Maximum change in IL2, IL3, IL8 and IL10 from baseline to day 3 post-op.
- The area under the curve for insulin concentration.