Clinical trial NCT03667950: Intraoperative Hyperspectral Imaging in Gastrointestinal Anastomoses
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Anastomosis
Keywords: anastomotic perfusion, tissue oxygen saturation
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* all gastrointestinal anastomoses

Exclusion Criteria:

* inability to consent

Primary outcomes:
measure: Anastomotic Perfusion: (Oxygenation (StO2)
timeFrame: direct during the Operation (ca. 15-20 Minutes)
measure: Anastomotic Perfusion: Tissue-Hemoglobin index
timeFrame: direct during the Operation (ca. 15-20 Minutes)
measure: Anastomotic Perfusion: Near Infrared Perfusion Index
timeFrame: direct during the Operation (ca. 15-20 Minutes)
measure: Anastomotic Perfusion: Tissue-Water-Index
timeFrame: direct during the Operation (ca. 15-20 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, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.