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临床试验/NCT02077673
NCT02077673已完成不适用

Robotic Assisted Laparoscopy Versus Open Gastroesophageal Resection; Effects on the Mesenteric Traction Reflex and PGI2 Levels

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
the occurence of anastomotic leakage

研究概览

简要总结

Gastroesophageal resection because of gastroesophageal junction (GEJ) adenocarcinoma is a massive surgical intervention. Currently, gastroesophageal cancer surgery is performed with upper laparotomy followed by thoracotomy at the Department of Surgical Gastroenterology, Rigshospitalet, Denmark. However, minimal invasive techniques (MIT), e.g. robotic assisted laparoscopy, is in the progress of being implemented in this field as they are hypothesized to be more beneficial for the patients, and in some aspects better than conventional laparoscopic surgery.

The operative procedure is often complicated by low blood pressure (systolic blood pressure less than 90 mm Hg is experienced in more than 30 % of the patients) and is probably accompanied by a reduced splanchnic microcirculatory flow, leading to increased morbidity. Hypotension may be due to several factors, among them are epidural analgesia, mesentery traction reflex, and inflammatory and vasoactive hormones.

Aim of the project

The aim of the project is, through a series of sub-projects, to validate or invalidate the relationship between changes in the microcirculatory blood flow in the stomach and the systemic hemodynamic changes. Furthermore, the aim is to assess the changes in the microcirculatory blood flow as a consequence of the thoracic epidural anesthesia. In addition, the aim is to assess the hypothesis that the mesenteric traction reflex and changes in the PGI2 levels may influence systemic hemodynamic changes, and that robotic assisted MIT will attenuate the mesenteric traction reflex and changes in PGI2 compared to open surgery.

详细描述

Background:

Gastroesophageal resection because of gastroesophageal junction (GEJ) adenocarcinoma is a massive surgical intervention. Nevertheless, surgery is the only treatment with significant long-term survival. Currently, gastroesophageal cancer surgery is performed with upper laparotomy followed by thoracotomy at the Department of Surgical Gastroenterology, Rigshospitalet, Denmark. However, minimal invasive techniques (MIT), e.g. robotic assisted laparoscopy, is in the progress of being implemented in this field as they are hypothesized to be more beneficial for the patients, and in some aspects better than conventional laparoscopic surgery [1]. The benefits of MIT are believed to be due to several factors, a smaller surgical stress response [2] and less pain [3] resulting in earlier mobilization, to mention a few.

When reconstructing the gastrointestinal continuity, a gastric tube is prepared from the upper part of the remaining stomach. It is challenging to visualize, if the remaining stomach has adequate blood supply. Earlier studies have shown an up to 70 % reduction in blood flow, to the upper part of the remnant stomach [4-6], and ischemia is one of the most significant causes of anastomotic leakage [7, 8]. Anastomotic leakage occurs in up to 10 % of the patients and is fatal in up to 50 %. Furthermore, a recent study originated from the investigators department demonstrated, that patients experiencing anastomotic leakage after gastroesophageal cancer resection, have a significantly reduced long-term survival, even when early death and other postoperative complications were accounted for [9]. The overall 5-year survival rates in patients with and without anastomotic leakage were 20 and 35 %, respectively. Therefore, sufficient blood flow to the area of anastomosis is of paramount concern. Different techniques have been used in the attempt to assess the microcirculation during gastroesophageal resection [5, 10-13]. However, none of these techniques has proven to be practical, reliable, and time-efficient, and therefore not being routinely implemented in the clinical settings.

During open gastroesophageal resection, hypotension is common (systolic blood pressure less than 90 mm Hg is experienced in more than 30 % of the patients) and is probably accompanied by a reduced gastric microcirculatory flow. The hypotension may be due to several factors;

  • Sympathic nerve system blockage due to thoracic epidural neuraxial anesthesia: Several studies have found reduced splanchnic flow after epidural anesthesia, which was associated with a decrease in systemic resistance and mean arterial pressure [14, 15]. The impact of the time-point for activation of epidural analgesia, on complications in the postoperative period is unknown. An unpublished study (Nielsen T: "Increased cardiac output after Whipple's procedure for pancreatic cancer") suggests that early activation during operation leads to significantly longer stay in the recovery ward after the surgery.
  • The initial manipulation of viscera, results in a mesenteric traction reflex (also called eventration syndrome) with vasodilatation and secondary hypotension [16, 17]. The reason for mesenteric traction reflex is unknown, but is believed to be elicited by traction on the mesenterial blood vessels, resulting in a local release of prostacyclin (PGI2) from the endothelium. This reflex has mainly been shown to occur during pancreatic, gastric and aortic surgery, where manipulation of the mesenteric root is inevitable [18-21]. PGI2 is a potent vasodilatator, with inhibitory effect on platelet aggression and on vascular smooth cell proliferation [22-24].

研究设计

研究类型
Observational
观察模型
Case Only
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 diagnosed with adenocarcinoma in the gastroesophageal junction
  • Patients assumed to be resectable

排除标准

  • lack of consent
  • non-adenocarcinomas

结局指标

主要结局

the occurence of anastomotic leakage

时间窗: 7 days post-operative

Anastomotic insufficiency is defined as leakage identified by: 1. X-ray of the esophagus with water-soluble contrast on the 7.th day after operation, or 2. CT-scan because of clinical signs (e.g. fever, pain), or 3. Gastroscopy in critically ill patients.

次要结局

  • The occurrence of Mesenteric Traction Reflex(the initial 60 minutes of surgery)

研究者

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

Rikard Ambrus

MD

Rigshospitalet, Denmark

研究点 (1)

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