Complications of PerfusionNCT02902549
Real-time Quantitative Optical Perfusion Imaging in Surgery
An observational study of Complications of Perfusion, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Surgeons are nowadays unable to visualize and quantitatively evaluate microvascularisation in real-time during surgery. Complications due to vascular compromise are a major problem, especially in reconstructive surgery. Poor blood perfusion leads to ischemia and even tissue necrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complications of Perfusion
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2015to Dec 2017
- 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: Adult patients receiving reconstructive surgical treatment in the Academic Medical Center: 20 patients receiving free flap reconstructive surgery, and 20 patients receiving thoracolaparoscopic esophagectomy with gastric tube reconstruction. Patients will be selected irrespective of medical history, ethnic background or gender, stated that a physician of the department of Biomedical Engineering and Physics is available at time of surgery.
Who may be able to join
- Age ≥ 18 years - Scheduled for reconstructive surgery with free flap reconstruction or laparoscopic transhiatal and 3-stage transthoracic gastric tube surgery.
Who cannot join
- Allergic to iodide (indocyanine green)
- Hyper-thyroidism
- Breastfeeding
- No informed consent
- Allergic to ephedrine
- Ischaemic heart disease
Show all 9Show fewer
- Thyrotoxicosis
- Autonomic thyroid adenomas
- Intraoperative hypertension or tachycardia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-time Quantitative Optical Perfusion Imaging in Surgery: a Prospective, Observational, In-vivo, Human, Single-center Study
Surgeons are nowadays unable to visualize and quantitatively evaluate microvascularisation in real-time during surgery. Complications due to vascular compromise are a major problem, especially in reconstructive surgery. Poor blood perfusion leads to ischemia and even tissue necrosis. If, however, perfusion and ischemia could be monitored during surgery, then surgeons could change their reconstructive design and the anaesthesiologists could improve perfusion with fluids, inotropes or vasopressors, if necessary. Surgeons therefore need a tool that is able to image in high resolution (microvascularisation), direct, intra-operative, in 3D (to image thrombosis, luminal narrowing or distinct overlaying vessels) and that produces quantitative data to objectify image interpretation.
Optical techniques, based on the interaction of light with tissue, are able to image tissue at high resolution and in real-time. These techniques are FDA-approved and have emerged as powerful diagnostic tools in different departments of medicine, such as ophthalmology for visualizing retina vascularisation and dermatology for skin diagnostics.
In this study, investigators hypothesize that four novel optical technologies: Fluorescence Imaging, Laser Speckle Contrast Imaging, Optical Coherence Tomography and Sidestream Darkfield Microscopy are able to quantitatively image perfusion in real-time during surgery.
Read the detailed description
Primary objective - Perfusion will be measured with all the techniques focussed on 4 areas; from 'good' to 'decreased' perfusion (biologically)
Fluorescence Imaging (FI): Time to intensity measurements at four sides Laser Speckle Contrast Imaging (LSCI): Perfusion Units Optical Coherence Tomography (OCT): Vessel density \& decorrelation time Sidestream Darkfield Microscopy (SDF): Total vessel density, proportion of perfused vessels, perfused vessel density, max flow index, De Backer score, perfusion in mm/sec.
Differences in parameters between the four sites will be statistically be compared.
Secondary objectives
- Relation of parameters to patient outcome in terms of adverse events.
- Conditions
- Complications of Perfusion
- Keywords
- Optical Coherence Tomography, Fluorescence Imaging, Sidestream Darkfield Microscopy, Laser Speckle Contrast Imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with OCT.
- Perfusion will be imaged with OCT and measured in total vessel density.
Measured: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
Perfusion will be imaged with SDF and measured in microvascular flow index.
Measured: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with LSCI.
flux in perfusion units (LSCI)
Measured: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with FI.
intensity/time (FI)
Measured: 1 year
Secondary outcomes (9)
Distance of watershed to fundus (GT) or artery to tip (flap)
In the FI images the distance between the end of the right gastroepiploic artery and the fundus, and the distance between the artery entry and tip of the flap can be calculated.
Measured: 1 year
Measurement-time during surgery
time in minutes will be calculated during measurements
Measured: 30 minutes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with OCT.
- Perfusion will be imaged with OCT and measured in decorrelation time.
Measured: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
Perfusion will be imaged with SDF and measured in total vessel density.
Measured: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
Perfusion will be imaged with SDF and measured in perfused vessel density.
Measured: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
Perfusion will be imaged with SDF and measured in proportion of perfused vessels.
Measured: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
Perfusion will be imaged with SDF and measured in De Backer Score.
Measured: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
Perfusion will be imaged with SDF and measured in velocity in mm/sec.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionDec 2017
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 Complications of PerfusionStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Quest Medical Imaging
- Responsible party
- Principal investigator, S.S. Gisbertz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902549
- Sponsor's protocol ID
- NL52377.018.15
- Status last verified
- Feb 2018
- First submitted
- 24 Jan 2016
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Jansen SM, de Bruin DM, van Berge Henegouwen MI, Strackee SD, Veelo DP, van Leeuwen TG, Gisbertz SS. Can we predict necrosis intra-operatively? Real-time optical quantitative perfusion imaging in surgery: study protocol for a prospective, observational, in vivo pilot study. Pilot Feasibility Stud. 2017 Nov 25;3:65. doi: 10.1186/s40814-017-0204-1. eCollection 2017.
PubMed 29209513
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Quantitative Optical Perfusion Imaging in Surgery: a Prospective, Observational, In-vivo, Human, Single-center Study
- ClinicalTrials.gov ID
- NCT02902549
- Acronym / sponsor ID
- NL52377.018.15
- Conditions
- Complications of Perfusion
- Keywords
- Optical Coherence Tomography, Fluorescence Imaging, Sidestream Darkfield Microscopy, Laser Speckle Contrast Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Quest Medical Imaging
- Study start
- Oct 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Sep 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.
Surgeons are nowadays unable to visualize and quantitatively evaluate microvascularisation in real-time during surgery. Complications due to vascular compromise are a major problem, especially in reconstructive surgery. Poor blood perfusion leads to ischemia and even tissue necrosis. If, however, perfusion and ischemia could be monitored during surgery, then surgeons could change their reconstructive design and the anaesthesiologists could improve perfusion with fluids, inotropes or vasopressors, if necessary. Surgeons therefore need a tool that is able to image in high resolution (microvascularisation), direct, intra-operative, in 3D (to image thrombosis, luminal narrowing or distinct overlaying vessels) and that produces quantitative data to objectify image interpretation.
Optical techniques, based on the interaction of light with tissue, are able to image tissue at high resolution and in real-time. These techniques are FDA-approved and have emerged as powerful diagnostic tools in different departments of medicine, such as ophthalmology for visualizing retina vascularisation and dermatology for skin diagnostics.
In this study, investigators hypothesize that four novel optical technologies: Fluorescence Imaging, Laser Speckle Contrast Imaging, Optical Coherence Tomography and Sidestream Darkfield Microscopy are able to quantitatively image perfusion in real-time during surgery.
Detailed description
Primary objective - Perfusion will be measured with all the techniques focussed on 4 areas; from 'good' to 'decreased' perfusion (biologically)
Fluorescence Imaging (FI): Time to intensity measurements at four sides Laser Speckle Contrast Imaging (LSCI): Perfusion Units Optical Coherence Tomography (OCT): Vessel density \& decorrelation time Sidestream Darkfield Microscopy (SDF): Total vessel density, proportion of perfused vessels, perfused vessel density, max flow index, De Backer score, perfusion in mm/sec.
Differences in parameters between the four sites will be statistically be compared.
Secondary objectives
- Relation of parameters to patient outcome in terms of adverse events.
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
- Adult patients receiving reconstructive surgical treatment in the Academic Medical Center: 20 patients receiving free flap reconstructive surgery, and 20 patients receiving thoracolaparoscopic esophagectomy with gastric tube reconstruction. Patients will be selected irrespective of medical history, ethnic background or gender, stated that a physician of the department of Biomedical Engineering and Physics is available at time of surgery.
Key inclusion criteria (1 listed)
- Age ≥ 18 years - Scheduled for reconstructive surgery with free flap reconstruction or laparoscopic transhiatal and 3-stage transthoracic gastric tube surgery.
Key exclusion criteria (9 listed)
- Allergic to iodide (indocyanine green)
- Hyper-thyroidism
- Breastfeeding
- No informed consent
- Allergic to ephedrine
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
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with OCT.
Time frame: 1 year
- Perfusion will be imaged with OCT and measured in total vessel density.
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
Time frame: 1 year
Perfusion will be imaged with SDF and measured in microvascular flow index.
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with LSCI.
Time frame: 1 year
flux in perfusion units (LSCI)
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with FI.
Time frame: 1 year
intensity/time (FI)
9 secondary outcomes
Distance of watershed to fundus (GT) or artery to tip (flap)
Time frame: 1 year
Measurement-time during surgery
Time frame: 30 minutes
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with OCT.
Time frame: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
Time frame: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
Time frame: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
Time frame: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
Time frame: 1 year
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
Time frame: 1 year
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 7 Feb 2018.
- Derived from this study: PubMed 29209513Jansen SM, de Bruin DM, van Berge Henegouwen MI, Strackee SD, Veelo DP, van Leeuwen TG, Gisbertz SS. Can we predict necrosis intra-operatively? Real-time optical quantitative perfusion imaging in surgery: study protocol for a prospective, observational, in vivo pilot study. Pilot Feasibility Stud. 2017 Nov 25;3:65. doi: 10.1186/s40814-017-0204-1. eCollection 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Complications of Perfusion, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) 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 9 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 7 Feb 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?
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with OCT. (time frame: 1 year). The study lists 4 primary outcomes in all. 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 NCT02902549, 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 7 Feb 2018; AzTrials last refreshed its copy on 28 Oct 2026.