HSIGI: Intraoperative Hyperspectral Imaging in Gastrointestinal Anastomoses

Sponsor

University of Leipzig (Other)

Overall Status

Unknown status

CT.gov ID

NCT03667950

Collaborator

(none)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Surgical Anastomosis	Procedure: Hyperspectral Imaging	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hyperspectral imaging diagnostic hyperspectral Imaging of the gastrointestinal anastomosis and calculating the anastomotic Perfusion measures	Procedure: Hyperspectral Imaging Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.

Arm

Intervention/Treatment

Experimental: hyperspectral imaging

diagnostic hyperspectral Imaging of the gastrointestinal anastomosis and calculating the anastomotic Perfusion measures

Procedure: Hyperspectral Imaging

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

Outcome Measures

Primary Outcome Measures

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 index [direct 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 Index [direct 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-Index [direct during the Operation (ca. 15-20 Minutes)]
Tissue-Water-Index in %: Existing water distribution in the tissue area under consideration (index value)

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

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, Dr., University of Leipzig

Study Documents (Full-Text)

None provided.

More Information

Publications

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, Dr., University of Leipzig

ClinicalTrials.gov Identifier:

NCT03667950

Other Study ID Numbers:

HSIGI

First Posted:

Sep 12, 2018

Last Update Posted:

Oct 31, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr. Boris Jansen-Winkeln, Dr., University of Leipzig

anastomotic perfusion, tissue oxygen saturation

Study Results

No Results Posted as of Oct 31, 2019