The Use of Indocyanine Green Near-infrared Fluorescence for Bowel Perfusion Quantitative Assessment in Order to Prevent Anastomotic Leakage in Colorectal Surgery (ICG-NIRF)

February 24, 2025 updated by: Vadim Kuznetsov

Indocyanine Green Near-infrared Fluorescence Bowel Perfusion Quantitative Assessment to Prevent Anastomotic Leakage in Colorectal Surgery: a Multicentre, Randomised, Controlled Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1268

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
    • Leningrad Region
      • Vsevolozhsk District, Leningrad Region, Russian Federation, 188640
        • BELOOSTROV Clinic of High Technologies
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: ICG-guided bowel perfusion assessment
ICG will be injected before anastomosis is created, to quantitatively assess the perfusion status of the bowel.
Placebo Comparator: The control group
The control group, where before the creation of the anastomosis, the intestinal blood flow will not be assessed.
Other: Conventional Bowel Anastomosis group
conventional perfusion assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-days Anastomotic Leakage (AL) rate
Time Frame: 30-days
Anastomotic leakage rate
30-days

Secondary Outcome Measures

Outcome Measure
Time Frame
complication rate
Time Frame: 30-days
30-days
mortality
Time Frame: 30-days
30-days
days in hospital stay
Time Frame: 90-days
90-days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vadim Kuznetsov

Investigators

  • Study Director: Victor Kashchenko, Doctor of Medical Sciences, BELOOSTROV Clinic of High Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBELOSTROVCOFHICG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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