The Use of Indocyanine Green Near-infrared Fluorescence for Bowel Perfusion Quantitative Assessme… (NCT06845306) | Clinical Trial Compass
Not Yet RecruitingPhase 3
The Use of Indocyanine Green Near-infrared Fluorescence for Bowel Perfusion Quantitative Assessment in Order to Prevent Anastomotic Leakage in Colorectal Surgery
Russia1,268 participantsStarted 2025-06-01
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.