Clinical trial NCT04226781: ICG vs. HSI in Gastrointestinal Resections
Official title: Comparison Between Fluorescenceimaging With Indocyaningreen (ICG) and Hyperspectralimagig (HSI) for Tissue Perfusion in Gastrointestinal Resections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anastomosis
Perfusion
Keywords: tissue perfusion
hyperspectral imaging
fluorescence imaging
idocyaningreen (ICG)
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* all gastrointestinal anastomoses

Exclusion Criteria:

* inability to consent
* allergy against indocyaningreen dye

Primary outcomes:
measure: Tissue oxygenation (StO2) in %
timeFrame: After the intraoperative Photo is taken, within 5 minutes
measure: Anastomotic Perfusion in arbitrary units
timeFrame: After the intraoperative Photo is taken, within 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig - AöR
state: Sachsen
Study officials:
affiliation: University of Leipzig
name: Boris Jansen-Winkeln, MD, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jansen-Winkeln B, Holfert N, Kohler 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.
citation: Jansen-Winkeln B, Maktabi M, Takoh JP, Rabe SM, Barberio M, Kohler 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.
citation: Jansen-Winkeln B, Germann I, Kohler H, Mehdorn M, Maktabi M, Sucher R, Barberio M, Chalopin C, Diana M, Moulla Y, Gockel I. Comparison of hyperspectral imaging and fluorescence angiography for the determination of the transection margin in colorectal resections-a comparative study. Int J Colorectal Dis. 2021 Feb;36(2):283-291. doi: 10.1007/s00384-020-03755-z. Epub 2020 Sep 23.