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Objective Grading of MTS With LSCI and Thermography (MTS LSCI)

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ClinicalTrials.gov Identifier: NCT04796493
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
August Adelsten Olsen, Rigshospitalet, Denmark

Study Description
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Brief Summary:

Mesenteric traction syndrome (MTS) is defined as hypotension, tachycardia and facial flushing in the first hour of surgery, caused by mesenteric traction/abdominal exploration. MTS occurs frequently during abdominal surgery, with incidence around 80 % during open surgery, and lower during minimally invasive surgery. MTS can be divided into different severities using the degree of facial flushing, with the most severe level of MTS being associated with increased postoperative morbidity.

Today MTS i diagnosed and graded subjectively by the surgical team, with marked difficulty and limitations. Therefore the investigators developed a cut-off value using the Laser Speckle Contrast Imaging (LSCI), which the investigators wish to confirm in a new cohort, while also examining whether LSCI is interchangeable with digital thermography, which is simpler and cheaper to perfom.

The investigators will measure facial perfusion during the first hour of surgery and take blood samples at predefined timepoints to use for biochemical verification of the different severities of MTS.

Three cohorts will be included 45 open esophagectomies or gastrectomies 50 whipple surgery 55 robot assisted esophagectomies or gastrectomies These patients will be use in multiple articles examining different aspects of MTS

One study examining LSCI and thermography for the identification and grading of MTS will use 60 patients undergoing open esophagectomy or gastrectomy or whipple surgery, in this study patients will not be excluded if they are found to be disseminated.


Condition or disease
Mesenteric Traction Syndrome

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Objective Grading of Mesenteric Traction Syndrome With Laser Speckle Contrast Imaging Interchangeable With Digital Thermography
Actual Study Start Date : March 16, 2021
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : May 31, 2023
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Severity of MTS - measured facial perfusion [ Time Frame: first hour of surgery ]
    Facial perfusion measured with LSCI and Digital Thermography


Secondary Outcome Measures :
  1. Biochemical markers of MTS - prostacyclin [ Time Frame: During surgery ]
  2. Hemodynamics [ Time Frame: During surgery ]
  3. Markers of postoperative impact of MTS - IL6 and endothelial damage markers [ Time Frame: During and after surgery ]
  4. 30-day postoperative morbidity [ Time Frame: 30 days post surgery ]
  5. Incidence of objective MTS during whipples procedure with methylprednisolone prophylaxis [ Time Frame: During surgery ]
  6. Incidence of objective MTS during minimally invasive surgery [ Time Frame: during surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

3 cohorts

  • open esophagectomies and gastrectomies
  • robotic assisted esophagectomies and gastrectomies
  • whipples procedure
Criteria

Inclusion Criteria:

  • Undergoing curative surgery for esopageal, gastric, doudenal or pancreatic cancer

Exclusion Criteria:

  • Known flushing disease
  • Patients recieving NSAID and corticosteroid presurgery, Whipple is allowed to recieve single dose of 125 mg Methylprednisone as part of the standard of care at our facility.
  • Palliative surgery
  • Surgery not completed due to disseminated disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04796493


Contacts
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Contact: August Olsen, PHD student +4521571240 ext 45 augustolsen2@gmail.com
Contact: Michael Achiam, Dr.med

Locations
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Denmark
Rigshospitalet Recruiting
København Ø, Hovedstaden, Denmark, 2100
Contact: August Olsen, PhD student    +4521571240    augustolsen2@gmail.com   
Sponsors and Collaborators
Rigshospitalet, Denmark
More Information
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Responsible Party: August Adelsten Olsen, MD PhD student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04796493    
Other Study ID Numbers: H-20058773
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes