ICG vs. HSI in Gastrointestinal Resections

Not Applicable

• Conditions: Perfusion; Anastomosis
• Interventions: Diagnostic Test: Indocyaningreen-Fluorescence imaging; Diagnostic Test: Hyperspectral-Imaging

• Registration Number: NCT04226781
• Lead Sponsor: University of Leipzig

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-01-02
• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-13
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-16
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• all gastrointestinal anastomoses

Exclusion Criteria

• inability to consent
• allergy against indocyaningreen dye

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICG	Indocyaningreen-Fluorescence imaging	Fluorescence imaging for blood Perfusion of the gastrointestinal tissue
HSI	Hyperspectral-Imaging	Hyperspectralimaging for blood Perfusion of the gastrointestinal tissue

Primary Outcome Measures

Name	Time	Method
Anastomotic Perfusion in arbitrary units	After the intraoperative Photo is taken, within 5 minutes	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.
Tissue oxygenation (StO2) in %	After the intraoperative Photo is taken, within 5 minutes	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.

Trial Locations

Locations (1)

Universitätsklinikum Leipzig - AöR; 🇩🇪 Leipzig, Sachsen, Germany