An interventional study of Blood samples and Measurement of microcirculation in Gastrointestinal Neoplasms and Mesenteric Traction Syndrome, sponsored by Rigshospitalet, Denmark. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-05.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Diagnostic
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:
Three different interventions will be examined during this prospective trial:
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.
Hypothesis and aim
It is the hypothesis of this project that the Mesenteric Traction Syndrome (MTS) is a common event during UGC-surgery and that the induction of the syndrome is an important factor in provoking further peri- and postoperative complications and in worsening the SSR. 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 development of complications.
Methods
75 patients undergoing UGC surgery (25 each of the three most common cancer types of UGC) will be included. This study will use a novel skin flushing measuring method called laser speckle contrast imaging (LSCI) to measure skin blood flow of the forehead. LSCI is a real-time and non-touch measuring device capable of measuring blood flow on a large field surface (15 cm x 20 cm). In parallel, inflammatory and hormonal stress biomarkers considered to be associated with SSR, will be measured. In this study, it is hypothesized, that by correlating a new method of quantifiable flushing measurement and known biomarkers, it is possible to relate the extent of flushing to the severity of hypotension and MTS and by proxy the extent of complications.
Furthermore, the participants will be exposed to head down tilt at three pre defined time points with subsequent monitoring of haemodynamics and SSR. This intervention is done to assess the patients' fluid status in the end of surgery as well as postoperatively, as hypovolemia is associated with postoperative complications.
Statistics
The incidence of MTS in UGC patients was previously unknown and power calculations was performed based on previous reported cases of MTS during abdominal surgery (incidence of 30% and 85%). 15 patients are required in each group in order to obtain a statistical power greater than 0.90 with an α-level of \< 0.05,. Groups of 25 patients are therefore chosen to ensure statistical significance.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's enrollment of 75 is above the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Patients under going Whipple's procedure, gastric resection and liver resection (n=75). Interventions: Blood samples obtained pre-, intra-, and one day postoperatively (n=15). Measurements of microcirculation using LSCI from procedure start and up to 60 min during surgery. Head down tilt of 20 degrees at three time points.
Other: Blood samples · Other: Measurement of microcirculation · Other: Head down tilt
15 arterial blood samples (pre-, intra- and one day postoperatively); no more than 180ml in total over two days.
Measurement of microcirculation with Laser Speckle Contrast Imaging (non-touch setup with no side effects); continuous measurement of the microvascular blood flow on the forehead up to 60 minutes starting one minute before the surgical procedure.
Also known as: LSCI
At three different time points the participants will be head down tilted in 20 degrees. End of surgery (A) One hour postoperatively (B) 18 hours postoperatively (C)
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.
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)
Time frame: 15 blood samples obtained pre-, intra-, and 18 hours postoperatively
Postoperative complications
All complications will be registered on every postoperative day until discharge.
Time frame: 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
The variable will be obtained during the surgical procedure using modelflow (Nexfin, BMEYE B.V. Amsterdam, Holland)
Time frame: Continuous measurements intra- and postoperatively.
Relative changes in microcirculation from baseline during surgery measured in flux-units
Laser Speckle Contrast Imaging (LSCI) is a real-time and non-touch measuring device capable of measuring blood flow on a large field surface (0.5 cm x 0.7 cm up to 15 cm x 20 cm). The infrared LSCI camera is placed at a distance of 20-30 cm and measures the relative flow (flux) at a depth of 1-2 mm by infrared light reflected from circulating erythrocytes in the micro-vessels. The technique will be used for quantifying facial flushing (i.e. increased blood flow to the facial region) during the first hour of surgery, when the MTS is frequently observed.
Time frame: A continuous measurement starting one minute prior to the surgical procedure and terminates after 60 minutes.
30-days and 90-days mortality
Time frame: 30-days and 90-days mortality
Length of stay
Time frame: Expected time frame of 10 days in average.
Relative changes in median arterial pressure from baseline measured in mmHg
The variable will be obtained during the surgical procedure using modelflow (Nexfin, BMEYE B.V. Amsterdam, Holland)
Time frame: Continuous measurements intra- and postoperatively.
Relative changes in cardiac output from baseline measured in litres per minute
The variable will be obtained during the surgical procedure using modelflow (Nexfin, BMEYE B.V. Amsterdam, Holland)
Time frame: Continuous measurements intra- and postoperatively.
Relative changes in systemic vascular resistance from baseline measured in dyn.s/cm5
The variable will be obtained during the surgical procedure using modelflow (Nexfin, BMEYE B.V. Amsterdam, Holland)
Time frame: Continuous measurements intra- and postoperatively.
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Rigshospitalet, Denmark