ICG vs. HSI in Gastrointestinal Resections

Study Overview
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Brief Summary
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In this study, gastrointestinal anastomoses are examined with a hyperspectral camera and after this the investigators use the Standard Routine ICG-Imaging. At the end, both methods will be compared..

Detailed Description
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All gastrointestinal anastomoses were examined in all patients with written informed consent. As Standard in our clinical Routine the tissue perfusion is measured with fluorescence Imaging and Indocyaningreen (ICG). In this study the investigators use the Hyperspectral-Camera (HSI-Camera) as new method. The measurements were performed like described before, using the TIVITA Tissue system (Diaspective Vision GmbH, Am Salzhaff, Germany). This HSI-camera provides hyperspectral images with a high spectral resolution (5 nm) in the visible and near infrared range (500-1000 nm). A RGB image and 4 false color images that represent physiologic parameters are intraoperatively provided by an analysis software. This work is focused on tissue oxygenation (StO2), which represents the relative blood oxygenation in the microcirculation of superficial tissue layers (approximately 1 mm) and the near-infrared (NIR) Perfusion Index, representing tissue layers in 4-6 mm penetration depth. As Standard method ICG-Fluorescence Imaging is used. After the procedure the Perfusion data of both Systems is compared.

Official Title
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Comparison Between Fluorescenceimaging With Indocyaningreen (ICG) and Hyperspectralimagig (HSI) for Tissue Perfusion in Gastrointestinal Resections

Conditions
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Anastomosis, Perfusion

Intervention / Treatment
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* Diagnostic Test: Hyperspectral-Imaging
* Diagnostic Test: Indocyaningreen-Fluorescence imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all gastrointestinal anastomoses Exclusion Criteria: inability to consent allergy against indocyaningreen dye

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICG<br>Fluorescence imaging for blood Perfusion of the gastrointestinal tissue | Diagnostic Test: Indocyaningreen-Fluorescence imaging<br>* Photos were taken with the Fluorescence camera after injection of the indocyaningreen-dye of the gastrointestinal anastomosis<br>|
| Experimental: HSI<br>Hyperspectralimaging for blood Perfusion of the gastrointestinal tissue | Diagnostic Test: Hyperspectral-Imaging<br>* Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue oxygenation (StO2) in % | Directly after the photo has been taken, the distribution of the spectra and their intensity is evaluated with the help of computer assisted analysis software. The software calculates the tissue oxygen saturation value (StO2) in percent. These values are measured at a standardized distance from the anastomosis region. | After the intraoperative Photo is taken, within 5 minutes | 
| Anastomotic Perfusion in arbitrary units | Directly after the photo has been taken, the distribution of the spectra and their intensity is evaluated with the help of computer assisted analysis software. The software calculates the tissue perfusion in arbitrary units. (Method is described in attached literature) These values are measured at a standardized distance from the anastomosis region. | After the intraoperative Photo is taken, within 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tissue perfusion, hyperspectral imaging, fluorescence imaging, idocyaningreen (ICG)