NCT06845306Not 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
Indocyanine Green Near-infrared Fluorescence Bowel Perfusion Quantitative Assessment to Prevent Anastomotic Leakage in Colorectal Surgery: a Multicentre, Randomised, Controlled Study
Source: ClinicalTrials.gov · Last updated 25 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1268 (estimated)
- First submitted
- 20 Feb 2025
- Start date
- 1 Jun 2025
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Vadim Kuznetsov
- Diseases
- Colorectal cancer
- NCT number
- NCT06845306
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1268
- From 1 Jun 2025 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medical contraindications for surgical treatment
Other illness
- Colon obstruction, perforation or bleeding complicating the tumor
- Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
Other
- Pregnancy or breast feeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BELOOSTROV Clinic of High Technologies Coordinator of this site? Confirm its status | Vsevolozhsk District | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.