Intraoperative Hyperspectral Imaging in Gastrointestinal Anastomoses

Surgical Anastomosis Clinical Trial

— HSIGI  

Official title:

Vascular Border Zone Definition Using Intraoperative Hyperspectral Imaging for Resections and Reconstructions in Diseases of the Esophagus, Stomach, Pancreas, Small Intestine, Large Intestine and Rectum to Optimize Anastomotic Healing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03667950
• Other study ID #: HSIGI
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: January 2021

Study information

• Verified date: October 2019
• Source: University of Leipzig
• Contact: Boris Jansen-Winkeln, Dr.
• 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.

Description:

The anastomoses were examined under standardized conditions directly after creation. 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). The distance between camera and object was 30 cm for all measurements. The Number of Effective Pixels at this distance is 640 × 480 (x-, y-axis. The resulting field of view (FOV) has the dimensions 6.4 × 4.8 cm2 and a spatial resolution of 0.1 mm/pixel. The FOV is illuminated by 8 halogen spots (20 W each). The ceiling lights and other light sources were switched off, to avoid artifacts during the measurement (approximately 10 seconds). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2021
• Est. primary completion date: December 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

Related Conditions & MeSH terms

• Surgical Anastomosis

Intervention

Procedure:
• Hyperspectral Imaging
Photos were taken with the hyperspectral camera 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 (1)

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	Anastomotic Perfusion: (Oxygenation (StO2)	Oxygenation (StO2) in %: Relative O2 saturation of the blood immicrocircular system in superficial tissue layers (penetration depth: approx. 1 mm)	direct during the Operation (ca. 15-20 Minutes)
Primary	Anastomotic Perfusion: Tissue-Hemoglobin index	Tissue Hemoglobin index in %: Existing hemoglobin distribution in the microcircular system of the tissue area under consideration (index value)	direct during the Operation (ca. 15-20 Minutes)
Primary	Anastomotic Perfusion: Near Infrared Perfusion Index	Near Infrared Perfusion Index in %: Relative O2 saturation of the blood immicrocircular system in deeper tissue layers (penetration depth: 4-6mm; index value)	direct during the Operation (ca. 15-20 Minutes)
Primary	Anastomotic Perfusion: Tissue-Water-Index	Tissue-Water-Index in %: Existing water distribution in the tissue area under consideration (index value)	direct during the Operation (ca. 15-20 Minutes)