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Intraoperative Hyperspectral Imaging in Gastrointestinal Anastomoses

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03667950
Acronym
HSIGI
Enrollment
200
Registered
2018-09-12
Start date
2018-08-01
Completion date
2021-01-31
Last updated
2019-10-31

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

Conditions

Surgical Anastomosis

Keywords

anastomotic perfusion, tissue oxygen saturation

Brief summary

In this study, gastrointestinal anastomoses are examined with a hyperspectral camera.

Detailed 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.

Interventions

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

Sponsors

University of Leipzig
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
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

Design outcomes

Primary

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

Countries

Germany

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026