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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Mesenteric Traction Syndrome

• Study Type: Observational
• Enrollment (Actual): 98

Contacts and Locations

Study Locations

• Denmark
  • Hovedstaden
    • København Ø, Hovedstaden, Denmark, 2100
      • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

3 cohorts

• open esophagectomies
• robotic assisted esophagectomies
• whipples procedure

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of MTS - measured facial perfusion	Facial perfusion measured with LSCI and Digital Thermography	first hour of surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Biochemical markers of MTS - prostacyclin	During surgery
Hemodynamics	During surgery
Markers of postoperative impact of MTS - IL6 and endothelial damage markers	During and after surgery
30-day postoperative morbidity	30 days post surgery
Incidence of objective MTS during whipples procedure with methylprednisolone prophylaxis	During surgery
Incidence of objective MTS during minimally invasive surgery	during surgery
PACU - fluid therapy administred at PACU	At the PostAnesthesia Care Unit following surgery. Typically one to two days
PACU - vasopressor requirements	At the PostAnesthesia Care Unit following surgery.Typically one to two days
PACU - length of stay	At the PostAnesthesia Care Unit following surgery. Typically one to two days
suPAR (soluble urokinase Plasminogen Activator Receptor).	baseline just prior to surgery

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: August Olsen, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Estimated): August 23, 2027

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: H-20058773

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No