An observational study in Gastroesophageal Junction Adenocarcinoma and Surgery, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-05.
Sponsored by Rigshospitalet, Denmark · Observational
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.
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;
Microcirculatory measurements:
Laser Speckle Contrast Imaging (LSCI) is a relatively new technique for microcirculatory monitoring. When laser light encounters a surface of an object, a random interference effect generates, called laser speckle contrast. The speckle pattern changes depending on the velocity of the object, and it is possible to get information regarding the object's movements, by the fluctuations in the speckle pattern. By measuring the concentration and velocity of blood cells, tissue perfusion may be assessed by LSCI technique. A real-time and non-touch measurement can be made on a large field (0.5 cm x 0.7 cm up to 15 cm x 20 cm). The camera is placed at a distance of 20-30 cm and measures the relative flow (flux) in the regions of interest. The measurement is at a depth of 1-2 mm by infrared light reflected from circulating erythrocytes in the micro-vessels.
Hypothesis and aim:
Robot-assisted laparoscopic surgery alters the hemodynamics and microcirculation in the splanchnic system by reduced release of vasoactive substances, such as PGI2, compared to open surgery. With this study, the investigators wish to evaluate hemodynamic fluctuations and gastric microcirculation, and correlate these to serum levels of PGI2 at different stages of surgery in robotic assisted laparoscopic surgery and open surgery, respectively.
Methods:
2 × 25 consecutive patients selected for robotic assisted laparoscopic or open surgery. Hemodynamic assessments are according to standardized methods. Blood samples will be drawn at: 1) after induction of anesthesia, 2) when the peritoneum is first entered, 3) after 15 min. of surgery, 4) after liberation of stomach, 5) after abdominal skin closure, 6) after extraction of the gastric conduit into the thorax, 7) after formation of the anastomosis, 8) after thoracic skin closure, 9) 18 hours after surgery. LSCI will be used to measure the microcirculation at two locations (3 cm from the pylorus and just below the site of the anastomosis (the body)) on the stomach five times during open surgery, and twice during the thoracic part of robotic assisted laparoscopic surgery.
Statistics:
Statistical power-calculation is carried out on an expected difference of the occurrence of mesenteric traction reflex between patients operated with open vs. MIT. By using sample size of 50 comparing percentages where group one is 55 % and group two is 12 % [17], a requirement of 18 patients in each group is calculated in order to obtain a statistical power greater than 0.80 with a α-level of \<0.05.
2,004 studies on the registry are indexed under Adenocarcinoma; 374 are open to participants now.
This study's enrollment of 50 is below the median of 153 across 332 observational studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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The patients will be recruited at; The Department of Surgical Gastroenterology, Rigshospitalet, Denmark
Exclusion Criteria:
25 patients undergoing open gastroesophageal resection
25 patients under-going robotic-assisted gastroesophageal surgery
the occurence of anastomotic leakage
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.
Time frame: 7 days post-operative
The occurrence of Mesenteric Traction Reflex
The occurrence of Mesenteric Traction Reflex is defined as: 1. A decrease in systemic vascular resistance (SVR) of more than 20 % and / or 900 dyne • s • cm-5 in relation with surgery of the stomach 2. A decrease in systolic blood pressure of more than 20 % 3. Measurable increase of the release of PGI2 in relation to decreased SVR and blood pressure
Time frame: the initial 60 minutes of surgery
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Rigshospitalet, Denmark