Gastrointestinal NeoplasmsNCT02507414
Mesenteric Traction Syndrome During Upper Gastrointestinal Surgery
A study testing Blood samples, Measurement of microcirculation and Head down tilt in people with Gastrointestinal Neoplasms and Mesenteric Traction Syndrome, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasms, Mesenteric Traction Syndrome
- What is being tested?
- Blood samples, Measurement of microcirculation and Head down tilt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients under going either whipple's procedure, liver resection, or gastric resection.
Who cannot join
- Robotic assisted procedures
- Lack of informed consent
About this study
Official title: Characterization of the Mesenteric Traction Syndrome During Upper Gastrointestinal Surgery for Malignant Disease
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:
Read more
- 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.
Read the detailed description
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.
- Being tested
- Blood samples, Measurement of microcirculation, Head down tilt
- Keywords
- Mesenteric Traction Syndrome, Upper gastrointestinal cancer surgery
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
15 arterial blood samples (pre-, intra- and one day postoperatively); no more than 180ml in total over two days.
Measurement of microcirculationOther
Also called LSCI
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.
Head down tiltOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Other: Blood samples; Other: Measurement of microcirculation; Other: Head down tilt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 15 blood samples obtained pre-, intra-, and 18 hours postoperatively
Secondary outcomes (8)
Postoperative complications
All complications will be registered on every postoperative day until discharge.
Measured: 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)
Measured: 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.
Measured: A continuous measurement starting one minute prior to the surgical procedure and terminates after 60 minutes.
30-days and 90-days mortality
Measured: 30-days and 90-days mortality
Length of stay
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Continuous measurements intra- and postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startAug 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Rikard Ambrus, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507414
- Sponsor's protocol ID
- H-3-2014-021
- Status last verified
- Oct 2016
- First submitted
- 13 Jul 2015
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rizk NP, Bach PB, Schrag D, Bains MS, Turnbull AD, Karpeh M, Brennan MF, Rusch VW. The impact of complications on outcomes after resection for esophageal and gastroesophageal junction carcinoma. J Am Coll Surg. 2004 Jan;198(1):42-50. doi: 10.1016/j.jamcollsurg.2003.08.007.
PubMed 14698310Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.
PubMed 22552194Giannoudis PV, Dinopoulos H, Chalidis B, Hall GM. Surgical stress response. Injury. 2006 Dec;37 Suppl 5:S3-9. doi: 10.1016/S0020-1383(07)70005-0.
PubMed 17338909Kehlet H. The stress response to surgery: release mechanisms and the modifying effect of pain relief. Acta Chir Scand Suppl. 1989;550:22-8.
PubMed 2652970Pham TH, Perry KA, Enestvedt CK, Gareau D, Dolan JP, Sheppard BC, Jacques SL, Hunter JG. Decreased conduit perfusion measured by spectroscopy is associated with anastomotic complications. Ann Thorac Surg. 2011 Feb;91(2):380-5. doi: 10.1016/j.athoracsur.2010.10.006.
PubMed 21256274Avgerinos DV, Theoharides TC. Mesenteric traction syndrome or gut in distress. Int J Immunopathol Pharmacol. 2005 Apr-Jun;18(2):195-9. doi: 10.1177/039463200501800202.
PubMed 15888243Seltzer JL, Ritter DE, Starsnic MA, Marr AT. The hemodynamic response to traction on the abdominal mesentery. Anesthesiology. 1985 Jul;63(1):96-9. doi: 10.1097/00000542-198507000-00015. No abstract available.
PubMed 4014775Mythen MG, Webb AR. Intra-operative gut mucosal hypoperfusion is associated with increased post-operative complications and cost. Intensive Care Med. 1994;20(2):99-104. doi: 10.1007/BF01707662.
PubMed 8201106Ceppa EP, Fuh KC, Bulkley GB. Mesenteric hemodynamic response to circulatory shock. Curr Opin Crit Care. 2003 Apr;9(2):127-32. doi: 10.1097/00075198-200304000-00008.
PubMed 12657975
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Mesenteric Traction Syndrome During Upper Gastrointestinal Surgery for Malignant Disease
- ClinicalTrials.gov ID
- NCT02507414
- Acronym / sponsor ID
- H-3-2014-021
- Keywords
- Mesenteric Traction Syndrome, Upper gastrointestinal cancer surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- Aug 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Blood samples, Other: Measurement of microcirculation, Other: Head down tiltPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients under going either whipple's procedure, liver resection, or gastric resection.
Key exclusion criteria (2 listed)
- Robotic assisted procedures
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples15 arterial blood samples (pre-, intra- and one day postoperatively); no more than 180ml in total over two days. | Other | Group 1 |
| Measurement of microcirculationAlso: LSCIMeasurement 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. | Other | Group 1 |
| Head down tiltAt 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) | Other | Group 1 |
Primary outcome
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.
Time frame: 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)
8 secondary outcomes
Postoperative complications
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
Time frame: Continuous measurements intra- and postoperatively.
Relative changes in microcirculation from baseline during surgery measured in flux-units
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
Time frame: Continuous measurements intra- and postoperatively.
Relative changes in cardiac output from baseline measured in litres per minute
Time frame: Continuous measurements intra- and postoperatively.
Relative changes in systemic vascular resistance from baseline measured in dyn.s/cm5
Time frame: Continuous measurements intra- and postoperatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Background: PubMed 14698310Rizk NP, Bach PB, Schrag D, Bains MS, Turnbull AD, Karpeh M, Brennan MF, Rusch VW. The impact of complications on outcomes after resection for esophageal and gastroesophageal junction carcinoma. J Am Coll Surg. 2004 Jan;198(1):42-50. doi: 10.1016/j.jamcollsurg.2003.08.007.
- Background: PubMed 22552194Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.
- Background: PubMed 17338909Giannoudis PV, Dinopoulos H, Chalidis B, Hall GM. Surgical stress response. Injury. 2006 Dec;37 Suppl 5:S3-9. doi: 10.1016/S0020-1383(07)70005-0.
- Background: PubMed 2652970Kehlet H. The stress response to surgery: release mechanisms and the modifying effect of pain relief. Acta Chir Scand Suppl. 1989;550:22-8.
- Background: PubMed 21256274Pham TH, Perry KA, Enestvedt CK, Gareau D, Dolan JP, Sheppard BC, Jacques SL, Hunter JG. Decreased conduit perfusion measured by spectroscopy is associated with anastomotic complications. Ann Thorac Surg. 2011 Feb;91(2):380-5. doi: 10.1016/j.athoracsur.2010.10.006.
- Background: PubMed 15888243Avgerinos DV, Theoharides TC. Mesenteric traction syndrome or gut in distress. Int J Immunopathol Pharmacol. 2005 Apr-Jun;18(2):195-9. doi: 10.1177/039463200501800202.
- Background: PubMed 4014775Seltzer JL, Ritter DE, Starsnic MA, Marr AT. The hemodynamic response to traction on the abdominal mesentery. Anesthesiology. 1985 Jul;63(1):96-9. doi: 10.1097/00000542-198507000-00015. No abstract available.
- Background: PubMed 8201106Mythen MG, Webb AR. Intra-operative gut mucosal hypoperfusion is associated with increased post-operative complications and cost. Intensive Care Med. 1994;20(2):99-104. doi: 10.1007/BF01707662.
- Background: PubMed 12657975Ceppa EP, Fuh KC, Bulkley GB. Mesenteric hemodynamic response to circulatory shock. Curr Opin Crit Care. 2003 Apr;9(2):127-32. doi: 10.1097/00075198-200304000-00008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples, Measurement of microcirculation and Head down tilt in people with Gastrointestinal Neoplasms and Mesenteric Traction Syndrome, run by Copenhagen University Hospital, Rigshospitalet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 15 blood samples obtained pre-, intra-, and 18 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02507414, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.