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NCT Number: NCT06845306

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

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.

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Key information

Conditions

Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colonic Neoplasms Malignant Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

BELOOSTROV Clinic of High Technologies

Vsevolozhsk District, Leningradskaya Oblast', 188640, Russia

Location contact

Vadim Kuznetsov

CONTACT

[email protected]

+79043302184

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICG-guided bowel perfusion assessment

Drug

ICG will be injected before anastomosis is created, to quantitatively assess the perfusion status of the bowel.

Conventional Bowel Anastomosis group

Other

conventional perfusion assessment

Primary outcomes

  1. 30-days Anastomotic Leakage (AL) rate

    Time frame: 30-days

    Anastomotic leakage rate

Secondary outcomes

  1. complication rate

    Time frame: 30-days

  2. mortality

    Time frame: 30-days

  3. days in hospital stay

    Time frame: 90-days

Study contacts

Contact information is provided by the study sponsor or research team.

Timur Lankov

CONTACT

[email protected]

+79046077444

Vadim Kuznetsov

CONTACT

[email protected]

+79043302184

Sponsors and collaborators

Lead sponsor

Vadim Kuznetsov

Network

Registry information

Official study title

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

Acronym: ICG-NIRF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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