AnastomosisICGvHSINCT04226781
ICG vs. HSI in Gastrointestinal Resections
A study testing Hyperspectral-Imaging and Indocyaningreen-Fluorescence imaging in people with Anastomosis and Perfusion, run by University of Leipzig at 1 site in Germany.
Trial summary
In this study, gastrointestinal anastomoses are examined with a hyperspectral camera and after this the investigators use the Standard Routine ICG-Imaging. At the end, both methods will be compared.. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anastomosis, Perfusion
- What is being tested?
- Hyperspectral-Imaging and Indocyaningreen-Fluorescence imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jan 2020to 20 Jun 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
- allergy against indocyaningreen dye
Trial locations and contacts
1 site in 1 country.
Boris Jansen-Winkeln, MD, PD contact
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Leipzig - AöR
Leipzig, Saxony, 04103
Boris Jansen-Winkeln, MD, PD, +49-341-97- ext. 17200, boris.jansen-winkeln@medizin.uni-leipzig.de
Ines Gockel, MD, Prof., +49-341-97- ext. 17200, ines.gockel@medizin.uni-leipzig.de
About this study
Official title: Comparison Between Fluorescenceimaging With Indocyaningreen (ICG) and Hyperspectralimagig (HSI) for Tissue Perfusion in Gastrointestinal Resections
In this study, gastrointestinal anastomoses are examined with a hyperspectral camera and after this the investigators use the Standard Routine ICG-Imaging. At the end, both methods will be compared..
Read the detailed description
All gastrointestinal anastomoses were examined in all patients with written informed consent.
As Standard in our clinical Routine the tissue perfusion is measured with fluorescence Imaging and Indocyaningreen (ICG). In this study the investigators use the Hyperspectral-Camera (HSI-Camera) as new method. 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). 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.
As Standard method ICG-Fluorescence Imaging is used. After the procedure the Perfusion data of both Systems is compared.
- Conditions
- Anastomosis, Perfusion
- Being tested
- Hyperspectral-Imaging, Indocyaningreen-Fluorescence imaging
- Keywords
- tissue perfusion, hyperspectral imaging, fluorescence imaging, idocyaningreen (ICG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperspectral-ImagingDiagnostic test
Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.
Indocyaningreen-Fluorescence imagingDiagnostic test
Photos were taken with the Fluorescence camera after injection of the indocyaningreen-dye of the gastrointestinal anastomosis
| Study group | Role | What they receive |
|---|---|---|
| ICG | Active comparator | Fluorescence imaging for blood Perfusion of the gastrointestinal tissue Receives: Diagnostic Test: Indocyaningreen-Fluorescence imaging |
| HSI | Experimental | Hyperspectralimaging for blood Perfusion of the gastrointestinal tissue Receives: Diagnostic Test: Hyperspectral-Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tissue oxygenation (StO2) in %
Directly after the photo has been taken, the distribution of the spectra and their intensity is evaluated with the help of computer assisted analysis software. The software calculates the tissue oxygen saturation value (StO2) in percent. These values are measured at a standardized distance from the anastomosis region.
Measured: After the intraoperative Photo is taken, within 5 minutes
Anastomotic Perfusion in arbitrary units
Directly after the photo has been taken, the distribution of the spectra and their intensity is evaluated with the help of computer assisted analysis software. The software calculates the tissue perfusion in arbitrary units. (Method is described in attached literature) These values are measured at a standardized distance from the anastomosis region.
Measured: After the intraoperative Photo is taken, within 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start2 Jan 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion20 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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, MD, PD, Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226781
- Sponsor's protocol ID
- 202001
- Acronym
- ICGvHSI
- Status last verified
- Mar 2020
- First submitted
- 6 Jan 2020
- Last updated
- 16 Mar 2020
- 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, Holfert N, Kohler H, Moulla Y, Takoh JP, Rabe SM, Mehdorn M, Barberio M, Chalopin C, Neumuth T, Gockel I. Determination of the transection margin during colorectal resection with hyperspectral imaging (HSI). Int J Colorectal Dis. 2019 Apr;34(4):731-739. doi: 10.1007/s00384-019-03250-0. Epub 2019 Feb 2.
PubMed 30712079Jansen-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 29637244Jansen-Winkeln B, Germann I, Kohler H, Mehdorn M, Maktabi M, Sucher R, Barberio M, Chalopin C, Diana M, Moulla Y, Gockel I. Comparison of hyperspectral imaging and fluorescence angiography for the determination of the transection margin in colorectal resections-a comparative study. Int J Colorectal Dis. 2021 Feb;36(2):283-291. doi: 10.1007/s00384-020-03755-z. Epub 2020 Sep 23.
PubMed 32968892
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Fluorescenceimaging With Indocyaningreen (ICG) and Hyperspectralimagig (HSI) for Tissue Perfusion in Gastrointestinal Resections
- ClinicalTrials.gov ID
- NCT04226781
- Acronym / sponsor ID
- ICGvHSI / 202001
- Conditions
- Anastomosis, Perfusion
- Keywords
- tissue perfusion, hyperspectral imaging, fluorescence imaging, idocyaningreen (ICG)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 20 Jun 2021 (estimated)
- First posted
- 13 Jan 2020 (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 and after this the investigators use the Standard Routine ICG-Imaging. At the end, both methods will be compared..
Detailed description
All gastrointestinal anastomoses were examined in all patients with written informed consent.
As Standard in our clinical Routine the tissue perfusion is measured with fluorescence Imaging and Indocyaningreen (ICG). In this study the investigators use the Hyperspectral-Camera (HSI-Camera) as new method. 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). 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.
As Standard method ICG-Fluorescence Imaging is used. After the procedure the Perfusion data of both Systems is compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICG | Active comparator | Diagnostic Test: Indocyaningreen-Fluorescence imagingFluorescence imaging for blood Perfusion of the gastrointestinal tissue |
| HSI | Experimental | Diagnostic Test: Hyperspectral-ImagingHyperspectralimaging for blood Perfusion of the gastrointestinal tissue |
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 (2 listed)
- inability to consent
- allergy against indocyaningreen dye
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. | Diagnostic test | HSI |
| Indocyaningreen-Fluorescence imagingPhotos were taken with the Fluorescence camera after injection of the indocyaningreen-dye of the gastrointestinal anastomosis | Diagnostic test | ICG |
Primary outcome
Tissue oxygenation (StO2) in %
Time frame: After the intraoperative Photo is taken, within 5 minutes
Directly after the photo has been taken, the distribution of the spectra and their intensity is evaluated with the help of computer assisted analysis software. The software calculates the tissue oxygen saturation value (StO2) in percent. These values are measured at a standardized distance from the anastomosis region.
Anastomotic Perfusion in arbitrary units
Time frame: After the intraoperative Photo is taken, within 5 minutes
Directly after the photo has been taken, the distribution of the spectra and their intensity is evaluated with the help of computer assisted analysis software. The software calculates the tissue perfusion in arbitrary units. (Method is described in attached literature) These values are measured at a standardized distance from the anastomosis region.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Background: PubMed 30712079Jansen-Winkeln B, Holfert N, Kohler H, Moulla Y, Takoh JP, Rabe SM, Mehdorn M, Barberio M, Chalopin C, Neumuth T, Gockel I. Determination of the transection margin during colorectal resection with hyperspectral imaging (HSI). Int J Colorectal Dis. 2019 Apr;34(4):731-739. doi: 10.1007/s00384-019-03250-0. Epub 2019 Feb 2.
- 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.
- Derived from this study: PubMed 32968892Jansen-Winkeln B, Germann I, Kohler H, Mehdorn M, Maktabi M, Sucher R, Barberio M, Chalopin C, Diana M, Moulla Y, Gockel I. Comparison of hyperspectral imaging and fluorescence angiography for the determination of the transection margin in colorectal resections-a comparative study. Int J Colorectal Dis. 2021 Feb;36(2):283-291. doi: 10.1007/s00384-020-03755-z. Epub 2020 Sep 23.
- 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.
Boris Jansen-Winkeln, MD, PD contact
Boris Jansen-Winkeln, MD, PD 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 and Indocyaningreen-Fluorescence imaging in people with Anastomosis and Perfusion, 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 2 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 16 Mar 2020. 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, MD, PD (+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?
Tissue oxygenation (StO2) in % (time frame: After the intraoperative Photo is taken, within 5 minutes). The study lists 2 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 NCT04226781, which also lists 3 linked publications.
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 16 Mar 2020.