Characterization of the Mesenteric Traction Syndrome During Upper Gastrointestinal Surgery for Malignant Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 主要终点
- Relative changes in plasma-hormone concentrations (pro-ANP, PGF2, GLP-1, ACTH, cortisone, adrenaline, IL-1, IL-6, TNF-alfa and CRP (stress hormones)) from baseline.
研究概览
简要总结
It is the hypothesis of this project that the Mesenteric Traction Syndrome (MTS) is a common event during upper gastrointestinal cancer surgery (UGC surgery) and that the induction of the syndrome is an important factor in provoking further peri- and postoperative complications and in worsening the surgical stress response (SSR). The characteristics of MTS is hypotension, tachycardia, and flushing.
In order to uncover the role of MTS in cancer surgery and the effects on the oncological patients, the aim of the project is:
- To characterize MTS in patients undergoing three common forms of UGC surgery using a new objective methodology and by recording biomarkers suspected of playing a role in the pathophysiology of MTS and postoperative complication development.
Three different interventions will be examined during this prospective trial:
- Continuous measurement of microcirculation on the forehead using Laser Speckle Contrast Imaging during surgery.
- Analyses of plasma samples obtained pre-, intra-, and one day postoperatively.
- Continuous measurements of haemodynamic variables during surgery.
详细描述
Background
Surgical procedures for upper gastrointestinal cancer (UGC) induce a considerable risk of morbidity and mortality, and more than half of all UGC patients die within one year of diagnosis. Radical surgery is crucial to survival, but is associated with a high risk of complications which contributes to a poor long-term prognosis. Despite advances in surgical techniques and perioperative management, postoperative complications frequently occur.
An essential part of gastrointestinal cancer surgery is the reconstruction of the digestive tract by forming a gut-to-gut reconnection, an anastomosis. Especially during UGC surgery this reconstructive anastomosis is at high risk of insufficient healing and can thus leak intestinal contents into the surrounding tissues, causing life-threatening infections. Development of measures that can reduce the perioperative complications in these vulnerable patients is therefore of vital importance
Patients undergoing surgery for UGC are subjected to a substantial trauma reaction termed the surgical stress response (SSR). SSR is characterized by activation of the sympathetic nervous system, the endocrine system, as well as by immunological and hematological responses leading to hypotension, systemic and local inflammation. In addition, surgical stress can cause immunosuppression in response to the complex interaction of various hormones, cytokines and acute phase reactants. Furthermore, it has recently been reported that perioperative immunosuppression increases the incidence of cancer recurrence, growth of metastases and reduces survival.
A contributing factor to SSR, and possibly most importantly, to the rate of postoperative complications, may be the mesenteric traction syndrome (MTS). MTS arises when the organs of the abdomen are manipulated during surgery. One of the main symptoms is substantial circulatory changes (hypotension, tachycardia and subsequent flushing), which can potentially lead to surgical complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients under going either whipple's procedure, liver resection, or gastric resection.
排除标准
- •Robotic assisted procedures
- •Lack of informed consent
结局指标
主要结局
Relative changes in plasma-hormone concentrations (pro-ANP, PGF2, GLP-1, ACTH, cortisone, adrenaline, IL-1, IL-6, TNF-alfa and CRP (stress hormones)) from baseline.
时间窗: 15 blood samples obtained pre-, intra-, and 18 hours postoperatively
A: the day before the surgical procedure B: After induction of anaesthesia (baseline) C: 5 min intraoperatively D: 15 min intraoperatively E: 30 min intraoperatively F: 60 min intraoperatively G: 90 min intraoperatively H: 120 min intraoperatively I: 180 min intraoperatively J: Procedure ending K: 5 min after head down tilt (1) L: One hour after surgery M: 5 min after head down tilt (2) N: 18 hours postoperatively O: 5 min after head down tilt (3)
次要结局
- Relative changes in median arterial pressure from baseline measured in mmHg(Continuous measurements intra- and postoperatively.)
- Relative changes in systemic vascular resistance from baseline measured in dyn.s/cm5(Continuous measurements intra- and postoperatively.)
- Length of stay(Expected time frame of 10 days in average.)
- 30-days and 90-days mortality(30-days and 90-days mortality)
- Postoperative complications(Participants will be followed during the hospital stay, with an expected average of ten days)
- Relative changes in heart rate from baseline measured in beats per minute(Continuous measurements intra- and postoperatively.)
- Relative changes in microcirculation from baseline during surgery measured in flux-units(A continuous measurement starting one minute prior to the surgical procedure and terminates after 60 minutes.)
- Relative changes in cardiac output from baseline measured in litres per minute(Continuous measurements intra- and postoperatively.)
研究者
Rikard Ambrus
MD
Rigshospitalet, Denmark