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MTS LSCI: Objective Grading of MTS With LSCI and Thermography

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT04796493
Collaborator
(none)
150
Enrollment
1
Location
35.3
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated 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 :
    Mar 16, 2021
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Feb 23, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Severity of MTS - measured facial perfusion [first hour of surgery]

      Facial perfusion measured with LSCI and Digital Thermography

    Secondary Outcome Measures

    1. Biochemical markers of MTS - prostacyclin [During surgery]

    2. Hemodynamics [During surgery]

    3. Markers of postoperative impact of MTS - IL6 and endothelial damage markers [During and after surgery]

    4. 30-day postoperative morbidity [30 days post surgery]

    5. Incidence of objective MTS during whipples procedure with methylprednisolone prophylaxis [During surgery]

    6. Incidence of objective MTS during minimally invasive surgery [during surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 - patients will still be used in examination of LSCI and Thermography analysis even if desiminated

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rigshospitalet København Ø Hovedstaden Denmark 2100

    Sponsors and Collaborators

    • Rigshospitalet, Denmark

    Investigators

    • Principal Investigator: August Olsen, Rigshospitalet, Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    August Adelsten Olsen, MD PhD student, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT04796493
    Other Study ID Numbers:
    • H-20058773
    First Posted:
    Mar 15, 2021
    Last Update Posted:
    Apr 4, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Syndrome

    Study Results

    No Results Posted as of Apr 4, 2022