ICGvHSI: ICG vs. HSI in Gastrointestinal Resections

• Sponsor: University of Leipzig (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04226781
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.6
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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..

Condition or Disease	Intervention/Treatment	Phase
Anastomosis; Perfusion	Diagnostic Test: Hyperspectral-Imaging; Diagnostic Test: Indocyaningreen-Fluorescence imaging	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparison Between Fluorescenceimaging With Indocyaningreen (ICG) and Hyperspectralimagig (HSI) for Tissue Perfusion in Gastrointestinal Resections
• Actual Study Start Date: Jan 2, 2020
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Jun 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ICG Fluorescence imaging for blood Perfusion of the gastrointestinal tissue	Diagnostic Test: Indocyaningreen-Fluorescence imaging; Photos were taken with the Fluorescence camera after injection of the indocyaningreen-dye of the gastrointestinal anastomosis
Experimental: HSI Hyperspectralimaging for blood Perfusion of the gastrointestinal tissue	Diagnostic Test: Hyperspectral-Imaging; Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• all gastrointestinal anastomoses

Exclusion Criteria:

• inability to consent

• allergy against indocyaningreen dye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Leipzig - AöR	Leipzig	Sachsen	Germany	04103

Sponsors and Collaborators

• University of Leipzig

Investigators

• Principal Investigator: Boris Jansen-Winkeln, MD, PD, University of Leipzig

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Dr. Boris Jansen-Winkeln, Principal Investigator, Deputy Head of Department, Priv.-Doz. Dr. med. habil., University of Leipzig
• ClinicalTrials.gov Identifier: NCT04226781
• Other Study ID Numbers: 202001
• First Posted: Jan 13, 2020
• Last Update Posted: Mar 16, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Boris Jansen-Winkeln, Principal Investigator, Deputy Head of Department, Priv.-Doz. Dr. med. habil., University of Leipzig: tissue perfusion; hyperspectral imaging; fluorescence imaging; idocyaningreen (ICG)

Study Results

No Results Posted as of Mar 16, 2020