The Use of Indocyanine Green Near-infrared Fluorescence for Bowel Perfusion Quantitative Assessment in Order to Prevent Anastomotic Leakage in Colorectal Surgery
NCT ID: NCT06845306
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
1268 participants
INTERVENTIONAL
2025-06-01
2026-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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The ICG group
The ICG group, where, before creating the anastomosis, intestinal blood flow will be assessed using quantitative near-infrared fluorescence imaging using indocyanine green.
ICG-guided bowel perfusion assessment
ICG will be injected before anastomosis is created, to quantitatively assess the perfusion status of the bowel.
The control group
The control group, where before the creation of the anastomosis, the intestinal blood flow will not be assessed.
Conventional Bowel Anastomosis group
conventional perfusion assessment
Interventions
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ICG-guided bowel perfusion assessment
ICG will be injected before anastomosis is created, to quantitatively assess the perfusion status of the bowel.
Conventional Bowel Anastomosis group
conventional perfusion assessment
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Vadim Kuznetsov
NETWORK
Responsible Party
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Vadim Kuznetsov
The doctor is a researcher
Principal Investigators
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Victor Kashchenko, Doctor of Medical Sciences
Role: STUDY_DIRECTOR
BELOOSTROV Clinic of High Technologies
Locations
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BELOOSTROV Clinic of High Technologies
Vsevolozhsk District, Leningradskaya Oblast', Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TBELOSTROVCOFHICG
Identifier Type: -
Identifier Source: org_study_id
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