Mesenteric Traction SyndromeMTS LSCINCT04796493
Objective Grading of MTS With LSCI and Thermography
An observational study of Mesenteric Traction Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesenteric Traction Syndrome
- How many people
- 98 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Mar 2021to 23 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 3 cohorts * open esophagectomies * robotic assisted esophagectomies * whipples procedure
Who may be able to join
- Undergoing curative surgery for esopageal, gastric, doudenal or pancreatic cancer
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of MTS - measured facial perfusion
Facial perfusion measured with LSCI and Digital Thermography
Measured: first hour of surgery
Secondary outcomes (10)
Biochemical markers of MTS - prostacyclin
Measured: During surgery
Hemodynamics
Measured: During surgery
Markers of postoperative impact of MTS - IL6 and endothelial damage markers
Measured: During and after surgery
30-day postoperative morbidity
Measured: 30 days post surgery
Incidence of objective MTS during whipples procedure with methylprednisolone prophylaxis
Measured: During surgery
Incidence of objective MTS during minimally invasive surgery
Measured: during surgery
PACU - fluid therapy administred at PACU
Measured: At the PostAnesthesia Care Unit following surgery. Typically one to two days
PACU - vasopressor requirements
Measured: At the PostAnesthesia Care Unit following surgery.Typically one to two days
PACU - length of stay
Measured: At the PostAnesthesia Care Unit following surgery. Typically one to two days
suPAR (soluble urokinase Plasminogen Activator Receptor).
Measured: baseline just prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start16 Mar 2021
- Primary completion30 Jun 2023
- Study completion23 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenteric Traction SyndromeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, August Adelsten Olsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- August Olsen, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796493
- Sponsor's protocol ID
- H-20058773
- Acronym
- MTS LSCI
- Status last verified
- Aug 2026
- First submitted
- 8 Mar 2021
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Objective Grading of Mesenteric Traction Syndrome With Laser Speckle Contrast Imaging Interchangeable With Digital Thermography
- ClinicalTrials.gov ID
- NCT04796493
- Acronym / sponsor ID
- MTS LSCI / H-20058773
- Conditions
- Mesenteric Traction Syndrome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 23 Aug 2027 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3 cohorts * open esophagectomies * robotic assisted esophagectomies * whipples procedure
Key inclusion criteria (1 listed)
- Undergoing curative surgery for esopageal, gastric, doudenal or pancreatic cancer
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severity of MTS - measured facial perfusion
Time frame: first hour of surgery
Facial perfusion measured with LSCI and Digital Thermography
10 secondary outcomes
Biochemical markers of MTS - prostacyclin
Time frame: During surgery
Hemodynamics
Time frame: During surgery
Markers of postoperative impact of MTS - IL6 and endothelial damage markers
Time frame: During and after surgery
30-day postoperative morbidity
Time frame: 30 days post surgery
Incidence of objective MTS during whipples procedure with methylprednisolone prophylaxis
Time frame: During surgery
Incidence of objective MTS during minimally invasive surgery
Time frame: during surgery
PACU - fluid therapy administred at PACU
Time frame: At the PostAnesthesia Care Unit following surgery. Typically one to two days
PACU - vasopressor requirements
Time frame: At the PostAnesthesia Care Unit following surgery.Typically one to two days
PACU - length of stay
Time frame: At the PostAnesthesia Care Unit following surgery. Typically one to two days
suPAR (soluble urokinase Plasminogen Activator Receptor).
Time frame: baseline just prior to surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
August Olsen principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mesenteric Traction Syndrome, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of MTS - measured facial perfusion (time frame: first hour of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.