The Use of Indocyanine Green Near-infrared Fluorescence for Bowel Perfusion Quantitative Assessment in Order to Prevent Anastomotic Leakage in Colorectal Surgery
ICG-NIRF
Indocyanine Green Near-infrared Fluorescence Bowel Perfusion Quantitative Assessment to Prevent Anastomotic Leakage in Colorectal Surgery: a Multicentre, Randomised, Controlled Study
1 other identifier
interventional
1,268
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Jun 2025
Shorter than P25 for phase_3 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2025
CompletedFirst Posted
Study publicly available on registry
February 25, 2025
CompletedStudy Start
First participant enrolled
June 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
February 25, 2025
January 1, 2025
1.1 years
February 20, 2025
February 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
30-days Anastomotic Leakage (AL) rate
Anastomotic leakage rate
30-days
Secondary Outcomes (3)
complication rate
30-days
mortality
30-days
days in hospital stay
90-days
Study Arms (2)
The ICG group
ACTIVE COMPARATORThe 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 COMPARATORThe control group, where before the creation of the anastomosis, the intestinal blood flow will not be assessed.
Interventions
ICG will be injected before anastomosis is created, to quantitatively assess the perfusion status of the bowel.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vadim Kuznetsovlead
Study Sites (1)
BELOOSTROV Clinic of High Technologies
Vsevolozhsk District, Leningradskaya Oblast', 188640, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Victor Kashchenko, Doctor of Medical Sciences
BELOOSTROV Clinic of High Technologies
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Intraoperative imaging cannot blind the surgeon. The patient is only blinded prior to surgery.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- The doctor is a researcher
Study Record Dates
First Submitted
February 20, 2025
First Posted
February 25, 2025
Study Start
June 1, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
February 25, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF