Surgical AnastomosisHSIGINCT03667950
Intraoperative Hyperspectral Imaging in Gastrointestinal Anastomoses
A study testing Hyperspectral Imaging in people with Surgical Anastomosis, run by University of Leipzig at 1 site in Germany.
Trial summary
In this study, gastrointestinal anastomoses are examined with a hyperspectral camera. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Anastomosis
- What is being tested?
- Hyperspectral Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2018to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all gastrointestinal anastomoses
Who cannot join
- inability to consent
Trial locations and contacts
1 site in 1 country.
Ines Gockel, Prof. Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Leipzig - AöR
Leipzig, Saxony, 04103
About this study
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
In this study, gastrointestinal anastomoses are examined with a hyperspectral camera.
Read the 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.
- Conditions
- Surgical Anastomosis
- Being tested
- Hyperspectral Imaging
- Keywords
- anastomotic perfusion, tissue oxygen saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperspectral ImagingProcedure or surgery
Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| hyperspectral imaging | Experimental | diagnostic hyperspectral Imaging of the gastrointestinal anastomosis and calculating the anastomotic Perfusion measures Receives: Procedure: Hyperspectral Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anastomotic Perfusion: (Oxygenation (StO2)
Oxygenation (StO2) in %: Relative O2 saturation of the blood immicrocircular system in superficial tissue layers (penetration depth: approx. 1 mm)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: direct during the Operation (ca. 15-20 Minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start1 Aug 2018
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical AnastomosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Boris Jansen-Winkeln, University of Leipzig
- Investigators
- Boris Jansen-Winkeln, Dr., Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667950
- Sponsor's protocol ID
- HSIGI
- Acronym
- HSIGI
- Status last verified
- Oct 2019
- First submitted
- 30 Aug 2018
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no sharing
Publications
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.
PubMed 29637244
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03667950
- Acronym / sponsor ID
- HSIGI / HSIGI
- Conditions
- Surgical Anastomosis
- Keywords
- anastomotic perfusion, tissue oxygen saturation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hyperspectral imaging | Experimental | Procedure: Hyperspectral Imagingdiagnostic hyperspectral Imaging of the gastrointestinal anastomosis and calculating the anastomotic Perfusion measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all gastrointestinal anastomoses
Key exclusion criteria (1 listed)
- inability to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperspectral ImagingPhotos were taken with the hyperspectral camera of the gastrointestinal anastomosis. | Procedure or surgery | hyperspectral imaging |
Primary outcome
Anastomotic Perfusion: (Oxygenation (StO2)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: direct during the Operation (ca. 15-20 Minutes)
Tissue-Water-Index in %: Existing water distribution in the tissue area under consideration (index value)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Background: PubMed 29637244Jansen-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.
- Individual participant dataSharing planned: No. no sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Gockel, Prof. Dr. contact
Boris Jansen-Winkeln, Dr. principal investigator
University of Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperspectral Imaging in people with Surgical Anastomosis, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boris Jansen-Winkeln, Dr. (+49-314-97 ext. 17200, boris.jansen-winkeln@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic Perfusion: (Oxygenation (StO2) (time frame: direct during the Operation (ca. 15-20 Minutes)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03667950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.