ICG vs. HSI in Gastrointestinal Resections

Perfusion Clinical Trial

— ICGvHSI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04226781
• Other study ID #: 202001
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: June 20, 2021

Study information

• Verified date: March 2020
• Source: University of Leipzig
• Contact: Boris Jansen-Winkeln, MD, PD
• Phone: +49-314-97
• Email: boris.jansen-winkeln[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 20, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all gastrointestinal anastomoses

Exclusion Criteria:

• inability to consent

• allergy against indocyaningreen dye

Related Conditions & MeSH terms

• Anastomosis
• Perfusion

Intervention

Diagnostic Test:
• Hyperspectral-Imaging
Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.
• Indocyaningreen-Fluorescence imaging
Photos were taken with the Fluorescence camera after injection of the indocyaningreen-dye of the gastrointestinal anastomosis

Locations

Country	Name	City	State
Germany	Universitätsklinikum Leipzig - AöR	Leipzig	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Jansen-Winkeln B, Holfert N, Köhler H, Moulla Y, Takoh JP, Rabe SM, Mehdorn M, Barberio M, Chalopin C, Neumuth T, Gockel I. Determination of the transection margin during colorectal resection with hyperspectral imaging (HSI). Int J Colorectal Dis. 2019 Apr;34(4):731-739. doi: 10.1007/s00384-019-03250-0. Epub 2019 Feb 2. — View Citation

Jansen-Winkeln B, Maktabi M, Takoh JP, Rabe SM, Barberio M, Köhler H, Neumuth T, Melzer A, Chalopin C, Gockel I. [Hyperspectral imaging of gastrointestinal anastomoses]. Chirurg. 2018 Sep;89(9):717-725. doi: 10.1007/s00104-018-0633-2. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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