Clinical trial NCT02902549: Real-time Quantitative Optical Perfusion Imaging in Surgery
Official title: Real-time Quantitative Optical Perfusion Imaging in Surgery: a Prospective, Observational, In-vivo, Human, Single-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complications of Perfusion
Keywords: Optical Coherence Tomography
Fluorescence Imaging
Sidestream Darkfield Microscopy
Laser Speckle Contrast Imaging
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Quest Medical Imaging
First posted: 2016-09-16
Enrollment: 26
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: 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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years - Scheduled for reconstructive surgery with free flap reconstruction or laparoscopic transhiatal and 3-stage transthoracic gastric tube surgery.

Exclusion Criteria:

* Allergic to iodide (indocyanine green)
* Hyper-thyroidism
* Breastfeeding
* No informed consent
* Allergic to ephedrine
* Ischaemic heart disease
* Thyrotoxicosis
* Autonomic thyroid adenomas
* Intraoperative hypertension or tachycardia

Primary outcomes:
measure: Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with OCT.
timeFrame: 1 year
measure: Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
timeFrame: 1 year
measure: Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with LSCI.
timeFrame: 1 year
measure: Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with FI.
timeFrame: 1 year
Secondary outcomes:
measure: Distance of watershed to fundus (GT) or artery to tip (flap)
timeFrame: 1 year
measure: Measurement-time during surgery
timeFrame: 30 minutes
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 1 year
measure: Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with OCT.
timeFrame: 1 year
measure: Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
timeFrame: 1 year
measure: Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
timeFrame: 1 year
measure: Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
timeFrame: 1 year
measure: Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
timeFrame: 1 year
measure: Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.
timeFrame: 1 year
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
References:
citation: 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.