Colo-rectal CancerPhase 3ICG-NIRFNCT06845306
The Use of Indocyanine Green Near-infrared Fluorescence for Bowel Perfusion Quantitative Assessment in Order to Prevent Anastomotic Leakage in Colorectal Surgery
A Phase 3 study testing ICG-guided bowel perfusion assessment and Conventional Bowel Anastomosis group in people with Colo-rectal Cancer and Colonic Neoplasms Malignant, run by Vadim Kuznetsov at 1 site in Russia.
Trial summary
Anastomotic leakage (AL) is a serious complication after surgery for colon cancer, leading to a significant increase in mortality.Intraoperative fluorescence imaging using indocyanine green has proven to be a feasible and reproducible technique for real-time perfusion assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colo-rectal Cancer, Colonic Neoplasms Malignant
- What is being tested?
- ICG-guided bowel perfusion assessment and Conventional Bowel Anastomosis group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,268 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jun 2025to 1 Sep 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years old
- ECOG status 0-2
- Written informed consent
- histologically confirmed neoplasms malignant of the colon (caecum, ascending, transverse, descending, sigmoid)
- Scheduled for colorectal resection with primary anastomosis
Who cannot join
- Pregnancy or breast feeding
- Colon obstruction, perforation or bleeding complicating the tumor
- Medical contraindications for surgical treatment
- Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
BELOOSTROV Clinic of High Technologies
Vsevolozhsk District, Leningradskaya Oblast', 188640
Vadim Kuznetsov, +79043302184, vad33671477@yandex.ru
About this study
Official title: Indocyanine Green Near-infrared Fluorescence Bowel Perfusion Quantitative Assessment to Prevent Anastomotic Leakage in Colorectal Surgery: a Multicentre, Randomised, Controlled Study
Anastomotic leakage (AL) is a serious complication after surgery for colon cancer, leading to a significant increase in mortality.Intraoperative fluorescence imaging using indocyanine green has proven to be a feasible and reproducible technique for real-time perfusion assessment.
An increasing number of studies are being published on the use of indocyanine green (ICG) fluorescence imaging in colorectal cancer surgery, showing promising results.
Therefore, we propose conducting a multicenter, randomized controlled trial to investigate the potential use of quantitative assessment of near-infrared fluorescence imaging with indocyanine green (ICG) to prevent anastomotic leaks during colorectal surgery.
- Conditions
- Colo-rectal Cancer, Colonic Neoplasms Malignant
- Being tested
- ICG-guided bowel perfusion assessment, Conventional Bowel Anastomosis group
- Keywords
- ICG-guided quantitative assessment of bowel perfusion
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG-guided bowel perfusion assessmentDrug
ICG will be injected before anastomosis is created, to quantitatively assess the perfusion status of the bowel.
Conventional Bowel Anastomosis groupOther
conventional perfusion assessment
| Study group | Role | What they receive |
|---|---|---|
| The ICG group | Active comparator | The ICG group, where, before creating the anastomosis, intestinal blood flow will be assessed using quantitative near-infrared fluorescence imaging using indocyanine green. Receives: Drug: ICG-guided bowel perfusion assessment |
| The control group | Placebo comparator | The control group, where before the creation of the anastomosis, the intestinal blood flow will not be assessed. Receives: Other: Conventional Bowel Anastomosis group |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-days Anastomotic Leakage (AL) rate
Anastomotic leakage rate
Measured: 30-days
Secondary outcomes (3)
complication rate
Measured: 30-days
mortality
Measured: 30-days
days in hospital stay
Measured: 90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicentre randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vadim Kuznetsov
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Vadim Kuznetsov, the BELOOSTROV Clinic of High Technologies
- Investigators
- Victor Kashchenko, Doctor of Medical Sciences, Study director, BELOOSTROV Clinic of High Technologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845306
- Sponsor's protocol ID
- TBELOSTROVCOFHICG
- Acronym
- ICG-NIRF
- Status last verified
- Jan 2025
- First submitted
- 20 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indocyanine Green Near-infrared Fluorescence Bowel Perfusion Quantitative Assessment to Prevent Anastomotic Leakage in Colorectal Surgery: a Multicentre, Randomised, Controlled Study
- ClinicalTrials.gov ID
- NCT06845306
- Acronym / sponsor ID
- ICG-NIRF / TBELOSTROVCOFHICG
- Conditions
- Colo-rectal Cancer, Colonic Neoplasms Malignant
- Keywords
- ICG-guided quantitative assessment of bowel perfusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,268 participants (estimated)
- Lead sponsor
- Vadim KuznetsovResearch network
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 Feb 2025 (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.
Anastomotic leakage (AL) is a serious complication after surgery for colon cancer, leading to a significant increase in mortality.Intraoperative fluorescence imaging using indocyanine green has proven to be a feasible and reproducible technique for real-time perfusion assessment.
An increasing number of studies are being published on the use of indocyanine green (ICG) fluorescence imaging in colorectal cancer surgery, showing promising results.
Therefore, we propose conducting a multicenter, randomized controlled trial to investigate the potential use of quantitative assessment of near-infrared fluorescence imaging with indocyanine green (ICG) to prevent anastomotic leaks during colorectal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- multicentre randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| The ICG group | Active comparator | Drug: ICG-guided bowel perfusion assessmentThe ICG group, where, before creating the anastomosis, intestinal blood flow will be assessed using quantitative near-infrared fluorescence imaging using indocyanine green. |
| The control group | Placebo comparator | Other: Conventional Bowel Anastomosis groupThe control group, where before the creation of the anastomosis, the intestinal blood flow will not be assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged over 18 years old
- ECOG status 0-2
- Written informed consent
- histologically confirmed neoplasms malignant of the colon (caecum, ascending, transverse, descending, sigmoid)
- Scheduled for colorectal resection with primary anastomosis
Key exclusion criteria (4 listed)
- Pregnancy or breast feeding
- Colon obstruction, perforation or bleeding complicating the tumor
- Medical contraindications for surgical treatment
- Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
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 |
|---|---|---|
| ICG-guided bowel perfusion assessmentICG will be injected before anastomosis is created, to quantitatively assess the perfusion status of the bowel. | Drug | The ICG group |
| Conventional Bowel Anastomosis groupconventional perfusion assessment | Other | The control group |
Primary outcome
30-days Anastomotic Leakage (AL) rate
Time frame: 30-days
Anastomotic leakage rate
3 secondary outcomes
complication rate
Time frame: 30-days
mortality
Time frame: 30-days
days in hospital stay
Time frame: 90-days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: Yes
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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.
Victor Kashchenko, Doctor of Medical Sciences study director
BELOOSTROV Clinic of High Technologies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ICG-guided bowel perfusion assessment and Conventional Bowel Anastomosis group in people with Colo-rectal Cancer and Colonic Neoplasms Malignant, run by Vadim Kuznetsov at 1 site in Russia.
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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 25 Feb 2025. 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 Russia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vadim Kuznetsov (+79043302184, vad33671477@yandex.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-days Anastomotic Leakage (AL) rate (time frame: 30-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2025.