Objective Grading of MTS With LSCI and Thermography

NCT04796493 | Active Not Recruiting

• 1 other identifier: H-20058773
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 1

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 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

Conditions

Mesenteric Traction Syndrome

Outcome Measures

Primary Outcomes (1)

• Severity of MTS - measured facial perfusion

  Facial perfusion measured with LSCI and Digital Thermography

  first hour of surgery

Secondary Outcomes (10)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

3 cohorts * open esophagectomies * robotic assisted esophagectomies * whipples procedure

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

København Ø, Capital Region, 2100, Denmark

Location

Study Officials

• August Olsen

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD student

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 15, 2021
• Study Start: March 16, 2021
• Primary Completion: June 30, 2023
• Study Completion (Estimated): August 23, 2027
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

DK (1)