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ICG vs. HSI in Gastrointestinal Resections

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04226781
Acronym
ICGvHSI
Enrollment
50
Registered
2020-01-13
Start date
2020-01-02
Completion date
2021-06-20
Last updated
2020-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomosis, Perfusion

Keywords

tissue perfusion, hyperspectral imaging, fluorescence imaging, idocyaningreen (ICG)

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.

Interventions

DIAGNOSTIC_TESTHyperspectral-Imaging

Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.

DIAGNOSTIC_TESTIndocyaningreen-Fluorescence imaging

Photos were taken with the Fluorescence camera after injection of the indocyaningreen-dye of the gastrointestinal anastomosis

Sponsors

University of Leipzig
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* all gastrointestinal anastomoses

Exclusion criteria

* inability to consent * allergy against indocyaningreen dye

Design outcomes

Primary

MeasureTime frameDescription
Tissue oxygenation (StO2) in %After the intraoperative Photo is taken, within 5 minutesDirectly 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.
Anastomotic Perfusion in arbitrary unitsAfter the intraoperative Photo is taken, within 5 minutesDirectly 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.

Countries

Germany

Contacts

Primary ContactBoris Jansen-Winkeln, MD, PD
boris.jansen-winkeln@medizin.uni-leipzig.de+49-314-97
Backup ContactInes Gockel, MD, Prof.
ines.gockel@medizin.uni-leipzig.de+49-314-97

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026