Objective Grading of MTS With LSCI and Thermography

Mesenteric Traction Syndrome Clinical Trial

— MTS LSCI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04796493
• Other study ID #: H-20058773
• Status: Active, not recruiting
• Start date: March 16, 2021
• Est. completion date: August 23, 2027

Study information

• Verified date: February 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 98
• Est. completion date: August 23, 2027
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mesenteric Traction Syndrome
• Syndrome

Locations

Country	Name	City	State
Denmark	Rigshospitalet	København Ø	Hovedstaden

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of MTS - measured facial perfusion	Facial perfusion measured with LSCI and Digital Thermography	first hour of surgery
Secondary	Biochemical markers of MTS - prostacyclin		During surgery
Secondary	Hemodynamics		During surgery
Secondary	Markers of postoperative impact of MTS - IL6 and endothelial damage markers		During and after surgery
Secondary	30-day postoperative morbidity		30 days post surgery
Secondary	Incidence of objective MTS during whipples procedure with methylprednisolone prophylaxis		During surgery
Secondary	Incidence of objective MTS during minimally invasive surgery		during surgery
Secondary	PACU - fluid therapy administred at PACU		At the PostAnesthesia Care Unit following surgery. Typically one to two days
Secondary	PACU - vasopressor requirements		At the PostAnesthesia Care Unit following surgery.Typically one to two days
Secondary	PACU - length of stay		At the PostAnesthesia Care Unit following surgery. Typically one to two days
Secondary	suPAR (soluble urokinase Plasminogen Activator Receptor).		baseline just prior to surgery