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临床试验/NCT03974984
NCT03974984撤回不适用

Anesthesia and Immunological and Oxidative Stress in Relation to Abdominal Cancer Surgery

University of Copenhagen1 个研究点 分布在 1 个国家开始时间: 2020年6月4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
状态
撤回
试验地点
1
主要终点
Changes in neutrophil to lymphocyte ratio from preoperatively to day 1 postoperatively

研究概览

简要总结

Colorectal cancer is a frequent type of cancer accounting for 600,000 deaths annually. Surgical resection remains the best treatment for long-term survival. However, studies suggest that events in the perioperative period can induce metastasis formation and tumor growth. Tumor cells are released into the blood stream during surgery and the surgical stress may create a favorable environment for dissemination of tumor cells into distant tissue. This is done by a cascade of pro-cancerous catecholamines, prostaglandins and cytokines combined with an impaired anti-cancerous cell mediated immune response.

Until recently, focus on the anesthetic management of cancer patients has been limited. Relatively small alterations in the perioperative anesthetic management may play a tremendous role in tumor progression. Optimizing anesthesia to reduce the surgical stress response could improve recurrence rates and long-term outcomes for cancer patients by inhibiting perioperative metastasis formation. Regional anesthesia and amide local anesthetics are suspected to calm the immunologic storm of prostaglandins, catecholamines and cytokines when used in the perioperative phase. Furthermore, volatile inhalational anesthesia is thought to modulate the immune system in a pro-cancerous way, while propofol may have opposite effects. Many of these recent studies are statistically underpowered and susceptible to bias, and experts in cancer treatment and anesthesia have emphasized the need for further research within this specific field.

In this study the investigators aim to characterize differences in the immunologic response to surgery between inhalational, total intravenous and epidural anesthesia. This will be done by analyzing blood samples obtained in the perioperative period in patients undergoing different modes of anesthesia. The Investigators will furthermore describe the quality of recovery for patients anesthetized with the different methods

详细描述

Background and Purpose Colorectal cancer is a frequent type of cancer accounting for 600,000 deaths annually. Surgical resection remains the best treatment for long-term survival. However, studies suggest that events in the perioperative period can induce metastasis formation and tumor growth. Tumor cells are released into the blood stream during surgery and the surgical stress may create a favorable environment for dissemination of tumor cells into distant tissue. This is done by a cascade of pro-cancerous catecholamines, prostaglandins and cytokines combined with an impaired anti-cancerous cell mediated immune response.

Until recently, focus on the anesthetic management of cancer patients has been limited. Relatively small alterations in the perioperative anesthetic management may play a tremendous role in tumor progression. Optimizing anesthesia to reduce the surgical stress response could improve recurrence rates and long-term outcomes for cancer patients by inhibiting perioperative metastasis formation. Regional anesthesia and amide local anesthetics are suspected to calm the immunologic storm of prostaglandins, catecholamines and cytokines when used in the perioperative phase. Furthermore, volatile inhalational anesthesia is thought to modulate the immune system in a pro-cancerous way, while propofol may have opposite effects. Many of these recent studies are statistically underpowered and susceptible to bias, and experts in cancer treatment and anesthesia have emphasized the need for further research within this specific field.

In this study the investigators aim to characterize differences in the immunologic response to surgery between patients anesthetized with TIVA, epidural and NSAID and patients anesthetized with total intravenous anesthesia alone. This will be done by analyzing blood samples obtained in the perioperative period in patients undergoing different modes of anesthesia. The Investigators will furthermore describe the quality of recovery for patients anesthetized with the different methods Objectives The investigators hypothesize that the immunologic response to surgery and metastasis progression are influenced by the anesthetic technique.

Methods The study is initiated by Center for Surgical Science, Department of Surgery, Zealand University Hospital.

The study will take place at Hvidovre Hospital. This is a Danish university hospital. It supports 500,000 people and is one of four main emergency hospitals in Copenhagen Denmark. About 300 laparoscopic colon resections are performed at this facility every year.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years
  • Patients diagnosed with colorectal cancer (UICC stadium I-III) and scheduled for laparoscopic hemicolectomy.
  • ASA class I-III (Classification of the American Society of Anesthesiology)
  • Patients scheduled for anesthesia with propofol, remifentanil and epidural anesthesia.
  • Signed informed consent

排除标准

  • Known immune-defects
  • Patients undergoing neoadjuvant chemo or radiotherapy
  • History of previous cancer
  • Patients in immunomodulatory treatment within last 6 months
  • Daily oral or intravenous steroid-use
  • Patients that have undergone major surgery within one month before planned colon resection.

研究组 & 干预措施

The "Hvidovre population":

We will include patients undergoing laparoscopic hemicolectomy for cancer scheduled for anesthesia with total intravenous anesthesia combined with epidural anesthesia and perioperative NSAID on Hvidovre Hospital.

干预措施: Colon Resection (Procedure)

The "Hvidovre population":

We will include patients undergoing laparoscopic hemicolectomy for cancer scheduled for anesthesia with total intravenous anesthesia combined with epidural anesthesia and perioperative NSAID on Hvidovre Hospital.

干预措施: Epidural anesthesia (Procedure)

The "Hvidovre population":

We will include patients undergoing laparoscopic hemicolectomy for cancer scheduled for anesthesia with total intravenous anesthesia combined with epidural anesthesia and perioperative NSAID on Hvidovre Hospital.

干预措施: NSAID (Drug)

The "Zealand University Hospital population"

The immunological and oxidative stress in relation to abdominal surgery (IMOX) study is ongoing at Zealand University Hospital, Roskilde. It is a prospective explorative study cohort that consists of 60 patients undergoing laparoscopic colorectal cancer surgery.

The population has been anesthetized according to the standard operating procedure with either total intravenous anesthesia with propofol and remifentanil or volatile anesthesia with sevoflurane combined with a fast acting opioid (remifentanil or sufentanil). Patients anaesthetized with other techniques including epidural or other regional blocks will be excluded from the analysis.

干预措施: Colon Resection (Procedure)

结局指标

主要结局

Changes in neutrophil to lymphocyte ratio from preoperatively to day 1 postoperatively

时间窗: From preoperatively to day 1 postoperatively

Changes in neutrophil to lymphocyte ratio from day 0 to day 1. The ratio will be estimated using absolute numbers from differential counts pre and postoperatively. A high neutrophil to lymfocyte ratio is related to poor outcome after cancer surgery

次要结局

  • Changes in quality of recovery-15 score from preoperatively to day 1 postoperatively.(Difference from preoperatively to day 1 postoperatively)

研究者

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

Rune Børch Hasselager

Medical Doctor

University of Copenhagen

研究点 (1)

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