Intraoperative Hyperspectral Imaging in Gastrointestinal Anastomoses

Study Overview
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Brief Summary
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In this study, gastrointestinal anastomoses are examined with a hyperspectral camera.

Detailed Description
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The anastomoses were examined under standardized conditions directly after creation. 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). The distance between camera and object was 30 cm for all measurements. The Number of Effective Pixels at this distance is 640 × 480 (x-, y-axis. The resulting field of view (FOV) has the dimensions 6.4 × 4.8 cm2 and a spatial resolution of 0.1 mm/pixel. The FOV is illuminated by 8 halogen spots (20 W each). The ceiling lights and other light sources were switched off, to avoid artifacts during the measurement (approximately 10 seconds). 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.

Official Title
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Vascular Border Zone Definition Using Intraoperative Hyperspectral Imaging for Resections and Reconstructions in Diseases of the Esophagus, Stomach, Pancreas, Small Intestine, Large Intestine and Rectum to Optimize Anastomotic Healing

Conditions
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Surgical Anastomosis

Intervention / Treatment
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* Procedure: Hyperspectral Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all gastrointestinal anastomoses Exclusion Criteria: inability to consent

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hyperspectral imaging<br>diagnostic hyperspectral Imaging of the gastrointestinal anastomosis and calculating the anastomotic Perfusion measures | Procedure: 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 |
| --- | --- | --- |
| Anastomotic Perfusion: (Oxygenation (StO2) | Oxygenation (StO2) in %: Relative O2 saturation of the blood immicrocircular system in superficial tissue layers (penetration depth: approx. 1 mm) | direct during the Operation (ca. 15-20 Minutes) | 
| Anastomotic Perfusion: Tissue-Hemoglobin index | Tissue Hemoglobin index in %: Existing hemoglobin distribution in the microcircular system of the tissue area under consideration (index value) | direct during the Operation (ca. 15-20 Minutes) | 
| Anastomotic Perfusion: Near Infrared Perfusion Index | Near Infrared Perfusion Index in %: Relative O2 saturation of the blood immicrocircular system in deeper tissue layers (penetration depth: 4-6mm; index value) | direct during the Operation (ca. 15-20 Minutes) | 
| Anastomotic Perfusion: Tissue-Water-Index | Tissue-Water-Index in %: Existing water distribution in the tissue area under consideration (index value) | direct during the Operation (ca. 15-20 Minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anastomotic perfusion, tissue oxygen saturation