MicrocirculationIMAGESNCT02688946
Imaging Microcirculation and Gross Hemodynamics in Elective Colorectal Surgery
An observational study of Microcirculation, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
Rationale: The interaction between macro and microcirculation remains uncertain. Microvascular alterations can occur when systemic hemodynamic parameters are within an acceptable range. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microcirculation
- What is being tested?
- Not provided
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2014to 1 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 70 patients undergoing elective, gastrointestinal surgery. Surgical procedures included will be: * All forms of open colorectal surgery; * Pylorus Persevering PancreaticoDuodenectomy (PPPD); * Other procedures requiring small bowel resection for cancer; * Laparoscopic procedures with extracorporeal creation of the bowel anastomosis. These procedures provide unique access to different parts of the bowel. The PPPD procedure provides access to the mucosal and serosal side of the jejunum. Colorectal surgery provides access to both the serosal and mucosal side of the colon and the terminal ileum is sometimes also accessible. We expect to include around 2 patients per week.
Who may be able to join
- All patients aged >18 scheduled for elective, gastrointestinal surgery (as described above) with signed informed consent.
Who cannot join
- • Age <18 years;
- Atrial fibrillation (because of possible interference with FloTrac™/Vigileo™ cardiac output monitor);
- Left ventricular ejection fraction ≤30%;
- Serious pulmonary disease (resting pO2 <90% at room air);
- Renal failure (clearance <30 ml/min as calculated using the Modification of Diet in Renal Disease formula);
- Liver failure;
- No signed informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imaging Microcirculation And Gross Hemodynamic Assessment of the Bowel During Elective Colorectal Surgery
Rationale: The interaction between macro and microcirculation remains uncertain. Microvascular alterations can occur when systemic hemodynamic parameters are within an acceptable range. Perfusion changes and microvascular alterations may play an important role in anastomotic healing and the onset of anastomotic leakage after gastrointestinal surgery. Nowadays, assessment of bowel perfusion is macroscopically performed by the surgeon prior to anastomosis creation. However, local oxygen delivery may still be compromised as little is known about microcirculatory alterations of the bowel during colorectal surgery. Dark Field (DF) imaging is a technique using a stroboscopic light-emitting diode ring-based imaging modality incorporated in a hand-held device, which illuminates an area of interest and provides high contrast dynamic images of the microvasculature. DF-imaging enables to visualize the bowel's microcirculation.
Objective: To describe the human gastrointestinal microcirculation during gastrointestinal surgery under general anesthesia and to observe whether there is a correlation between bowel microcirculation and systemic hemodynamic parameters.
Read more
Study design: A prospective, single center, observational, clinical, pilot study.
Study population: 70 patients undergoing elective, gastrointestinal surgery during which the gastrointestinal tract is accessible for DF-imaging.
Main study parameters/endpoints: To describe human gastrointestinal microcirculation on both the serosal and mucosal side of the bowel during gastrointestinal surgery under general anesthesia. Main parameter: Microvascular perfusion is quantified using the Microvascular Flow Index (MFI).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The extend of burden and risk associated with participation is negligible. Using DF imaging on the bowel is a non-invasive technique requiring a minimal amount of time as is described in the study procedure. Previous studies did not show any safety concerns. Measuring will be performed under sterile conditions and the occurrence of tissue damage is highly unlikely. Patients are under general anesthesia and will thus not experience any inconvenience.
- Conditions
- Microcirculation
- Being tested
- Not provided
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not providedOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular flow index (MFI)
During surgery
Measured: Intra-operative
Secondary outcomes (4)
Perfused vessel density (PVD)
Measured: Intra-operative
Proportion of perfused vessels (PPV)
Measured: Intra-operative
Total vessel density (TVD)
Measured: Intra-operative
Heterogeneity index (HI)
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startMay 2014
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MicrocirculationStudies of the same condition, open and under way.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. P. Noordzij, St. Antonius Hospital
- Investigators
- Mat Van Iterson, PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688946
- Sponsor's protocol ID
- NL4833210014
- Acronym
- IMAGES
- Status last verified
- Mar 2018
- First submitted
- 18 Feb 2016
- Last updated
- 6 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Tavy ALM, de Bruin AFJ, van der Sloot K, Boerma EC, Ince C, Noordzij PG, Boerma D, van Iterson M. Effects of Thoracic Epidural Anaesthesia on the Serosal Microcirculation of the Human Small Intestine. World J Surg. 2018 Dec;42(12):3911-3917. doi: 10.1007/s00268-018-4746-z.
PubMed 30097706
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Microcirculation And Gross Hemodynamic Assessment of the Bowel During Elective Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02688946
- Acronym / sponsor ID
- IMAGES / NL4833210014
- Conditions
- Microcirculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 23 Feb 2016 (estimated)
- 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.
Rationale: The interaction between macro and microcirculation remains uncertain. Microvascular alterations can occur when systemic hemodynamic parameters are within an acceptable range. Perfusion changes and microvascular alterations may play an important role in anastomotic healing and the onset of anastomotic leakage after gastrointestinal surgery. Nowadays, assessment of bowel perfusion is macroscopically performed by the surgeon prior to anastomosis creation. However, local oxygen delivery may still be compromised as little is known about microcirculatory alterations of the bowel during colorectal surgery. Dark Field (DF) imaging is a technique using a stroboscopic light-emitting diode ring-based imaging modality incorporated in a hand-held device, which illuminates an area of interest and provides high contrast dynamic images of the microvasculature. DF-imaging enables to visualize the bowel's microcirculation.
Objective: To describe the human gastrointestinal microcirculation during gastrointestinal surgery under general anesthesia and to observe whether there is a correlation between bowel microcirculation and systemic hemodynamic parameters.
Study design: A prospective, single center, observational, clinical, pilot study.
Study population: 70 patients undergoing elective, gastrointestinal surgery during which the gastrointestinal tract is accessible for DF-imaging.
Main study parameters/endpoints: To describe human gastrointestinal microcirculation on both the serosal and mucosal side of the bowel during gastrointestinal surgery under general anesthesia. Main parameter: Microvascular perfusion is quantified using the Microvascular Flow Index (MFI).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The extend of burden and risk associated with participation is negligible. Using DF imaging on the bowel is a non-invasive technique requiring a minimal amount of time as is described in the study procedure. Previous studies did not show any safety concerns. Measuring will be performed under sterile conditions and the occurrence of tissue damage is highly unlikely. Patients are under general anesthesia and will thus not experience any inconvenience.
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
- 70 patients undergoing elective, gastrointestinal surgery. Surgical procedures included will be: * All forms of open colorectal surgery; * Pylorus Persevering PancreaticoDuodenectomy (PPPD); * Other procedures requiring small bowel resection for cancer; * Laparoscopic procedures with extracorporeal creation of the bowel anastomosis. These procedures provide unique access to different parts of the bowel. The PPPD procedure provides access to the mucosal and serosal side of the jejunum. Colorectal surgery provides access to both the serosal and mucosal side of the colon and the terminal ileum is sometimes also accessible. We expect to include around 2 patients per week.
Key inclusion criteria (1 listed)
- All patients aged >18 scheduled for elective, gastrointestinal surgery (as described above) with signed informed consent.
Key exclusion criteria (7 listed)
- • Age <18 years;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not provided | Other | – |
Primary outcome
Microvascular flow index (MFI)
Time frame: Intra-operative
During surgery
4 secondary outcomes
Perfused vessel density (PVD)
Time frame: Intra-operative
Proportion of perfused vessels (PPV)
Time frame: Intra-operative
Total vessel density (TVD)
Time frame: Intra-operative
Heterogeneity index (HI)
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
- Derived from this study: PubMed 30097706Tavy ALM, de Bruin AFJ, van der Sloot K, Boerma EC, Ince C, Noordzij PG, Boerma D, van Iterson M. Effects of Thoracic Epidural Anaesthesia on the Serosal Microcirculation of the Human Small Intestine. World J Surg. 2018 Dec;42(12):3911-3917. doi: 10.1007/s00268-018-4746-z.
- Individual participant dataSharing planned: Undecided
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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.
Mat Van Iterson, PhD principal investigator
St. Antonius Hospital
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 Microcirculation, run by St. Antonius Hospital at 1 site in Netherlands.
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 7 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: finished, as of the sponsor's last update on 6 Mar 2018. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Microvascular flow index (MFI) (time frame: Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02688946, which also lists 1 linked publication.
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 6 Mar 2018.