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NCT Number: NCT04796493

Objective Grading of MTS With LSCI and Thermography

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 is 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 we planned to include 45 open esophagectomies or gastrectomies 50 whipple surgery 20 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.

However we ended up including 37 open esophagectomies - due to few patients undergoing open esophagectomy, this were included over a time period of almost 2,5 years 50 whipple 11 Robotic esophagectomies - due to LSCI being impossible to use on robotic esophagectomies and thermography being diffciult to fit on these patients and as such not being feasible

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

København Ø, Capital Region, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Severity of MTS - measured facial perfusion

    Time frame: first hour of surgery

    Facial perfusion measured with LSCI and Digital Thermography

Secondary outcomes

  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

  7. PACU - fluid therapy administred at PACU

    Time frame: At the PostAnesthesia Care Unit following surgery. Typically one to two days

  8. PACU - vasopressor requirements

    Time frame: At the PostAnesthesia Care Unit following surgery.Typically one to two days

  9. PACU - length of stay

    Time frame: At the PostAnesthesia Care Unit following surgery. Typically one to two days

  10. suPAR (soluble urokinase Plasminogen Activator Receptor).

    Time frame: baseline just prior to surgery

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Is Objective Grading of Mesenteric Traction Syndrome With Laser Speckle Contrast Imaging Interchangeable With Digital Thermography

Acronym: MTS LSCI

Important dates

Study start
2021
Primary completion
2023
Study completion
2027
First posted
Mar 15, 2021
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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