Real-time Quantitative Optical Perfusion Imaging in Surgery

Completed

• Conditions: Complications of Perfusion

• Registration Number: NCT02902549
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-01-24
• Primary Completion: 2016-09
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with FI.	1 year	intensity/time (FI)
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with OCT.	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 LSCI.	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 SDF.	1 year	Perfusion will be imaged with SDF and measured in microvascular flow index.

Secondary Outcome Measures

Name	Time	Method
Distance of watershed to fundus (GT) or artery to tip (flap)	1 year	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.
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with OCT.	1 year	- Perfusion will be imaged with OCT and measured in decorrelation time.
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.	1 year	Perfusion will be imaged with SDF and measured in velocity in mm/sec.
Measurement-time during surgery	30 minutes	time in minutes will be calculated during measurements
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	1 year

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands