Real-time Quantitative Optical Perfusion Imaging in Surgery

NCT02902549 | Completed

• 1 other identifier: NL52377.018.15
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications of Perfusion

Keywords

Optical Coherence Tomography; Fluorescence Imaging; Sidestream Darkfield Microscopy; Laser Speckle Contrast Imaging

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (9)

• Distance of watershed to fundus (GT) or artery to tip (flap)

  1 year

• Measurement-time during surgery

  30 minutes

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  1 year

• Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with OCT.

  1 year

• Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 29209513 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr.

Study Record Dates

• First Submitted: January 24, 2016
• First Posted: September 16, 2016
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2017
• Last Updated: February 7, 2018

Record last verified: 2018-02

Locations

NL (1)