Real-time Quantitative Optical Perfusion Imaging in Surgery

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.

Study Overview

• Status: Completed
• Conditions: Complications of Perfusion

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 Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	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)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		1 year
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.	1 year
Measurement-time during surgery	time in minutes will be calculated during measurements	30 minutes
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.	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.	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.	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.	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.	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.	1 year

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Quest Medical Imaging

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 24, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; Fluorescence Imaging; Sidestream Darkfield Microscopy; Laser Speckle Contrast Imaging
• Other Study ID Numbers: NL52377.018.15