A Phase 3 interventional study of ICG-guided bowel perfusion assessment and Conventional Bowel Anastomosis group in Colo-rectal Cancer and Colonic Neoplasms Malignant, sponsored by Vadim Kuznetsov. Not yet recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by Vadim Kuznetsov · Phase 3, Interventional, and Treatment
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.
1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.
This study's planned enrollment of 1,268 is above the median of 89 across 1,067 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →This is the only study on the registry with Vadim Kuznetsov as lead sponsor.
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Exclusion Criteria:
The ICG group, where, before creating the anastomosis, intestinal blood flow will be assessed using quantitative near-infrared fluorescence imaging using indocyanine green.
Drug: ICG-guided bowel perfusion assessment
The control group, where before the creation of the anastomosis, the intestinal blood flow will not be assessed.
Other: Conventional Bowel Anastomosis group
ICG will be injected before anastomosis is created, to quantitatively assess the perfusion status of the bowel.
conventional perfusion assessment
30-days Anastomotic Leakage (AL) rate
Anastomotic leakage rate
Time frame: 30-days
complication rate
Time frame: 30-days
mortality
Time frame: 30-days
days in hospital stay
Time frame: 90-days
Plan to share: Yes
Supporting information: Study protocol, Informed consent form
No publications or documents are linked to this record.
Start is estimated for Jun 2025; primary completion for Jul 2026, 13 months later.
Of 50 phase 3 interventional studies under Colonic Neoplasms, half reached primary completion within 87 months of starting (the median), counting those still running; a quarter within 48 and three quarters within 128. This study's planned 13 months is below that.
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This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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