Clinical trial NCT04796493: Objective Grading of MTS With LSCI and Thermography
Official title: Is Objective Grading of Mesenteric Traction Syndrome With Laser Speckle Contrast Imaging Interchangeable With Digital Thermography
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Mesenteric Traction Syndrome
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3 cohorts

* open esophagectomies
* robotic assisted esophagectomies
* whipples procedure

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


Eligibility criteria: 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

Primary outcomes:
measure: Severity of MTS - measured facial perfusion
timeFrame: first hour of surgery
Secondary outcomes:
measure: Biochemical markers of MTS - prostacyclin
timeFrame: During surgery
measure: Hemodynamics
timeFrame: During surgery
measure: Markers of postoperative impact of MTS - IL6 and endothelial damage markers
timeFrame: During and after surgery
measure: 30-day postoperative morbidity
timeFrame: 30 days post surgery
measure: Incidence of objective MTS during whipples procedure with methylprednisolone prophylaxis
timeFrame: During surgery
measure: Incidence of objective MTS during minimally invasive surgery
timeFrame: during surgery
measure: PACU - fluid therapy administred at PACU
timeFrame: At the PostAnesthesia Care Unit following surgery. Typically one to two days
measure: PACU - vasopressor requirements
timeFrame: At the PostAnesthesia Care Unit following surgery.Typically one to two days
measure: PACU - length of stay
timeFrame: At the PostAnesthesia Care Unit following surgery. Typically one to two days
measure: suPAR (soluble urokinase Plasminogen Activator Receptor).
timeFrame: baseline just prior to surgery
Other outcomes:
Locations:
city: København Ø
country: Denmark
facility: Rigshospitalet
state: Hovedstaden
Study officials:
affiliation: Rigshospitalet, Denmark
name: August Olsen
role: PRINCIPAL_INVESTIGATOR
References: