Intraoperative Hyperspectral Imaging in Gastrointestinal Anastomoses
HSIGI
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
1 other identifier
interventional
200
1 country
1
Brief Summary
In this study, gastrointestinal anastomoses are examined with a hyperspectral camera.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
August 30, 2018
CompletedFirst Posted
Study publicly available on registry
September 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedOctober 31, 2019
October 1, 2019
2.3 years
August 30, 2018
October 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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)
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)
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)
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)
Study Arms (1)
hyperspectral imaging
EXPERIMENTALdiagnostic hyperspectral Imaging of the gastrointestinal anastomosis and calculating the anastomotic Perfusion measures
Interventions
Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.
Eligibility Criteria
You may qualify if:
- all gastrointestinal anastomoses
You may not qualify if:
- inability to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinikum Leipzig - AöR
Leipzig, Saxony, 04103, Germany
Related Publications (1)
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.
PMID: 29637244BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Boris Jansen-Winkeln, Dr.
University of Leipzig
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
August 30, 2018
First Posted
September 12, 2018
Study Start
August 1, 2018
Primary Completion
December 1, 2020
Study Completion
January 1, 2021
Last Updated
October 31, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share
no sharing