Menu
Not yet recruiting NCT06845306

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

Phase III Interventional Colo-rectal Cancer Colonic Neoplasms Malignant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ICG-guided bowel perfusion assessment, Conventional Bowel Anastomosis group.
Who it may be relevant to
Registry conditions: Colo-rectal Cancer, Colonic Neoplasms Malignant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug ICG-guided bowel perfusion assessment
    ICG will be injected before anastomosis is created, to quantitatively assess the perfusion status of the bowel.
  • Other Conventional Bowel Anastomosis group
    conventional perfusion assessment

Primary outcome measures

  • 30-days Anastomotic Leakage (AL) rate [Time frame: 30-days]
Secondary outcome measures (3)
  • complication rate [Time frame: 30-days]
  • mortality [Time frame: 30-days]
  • days in hospital stay [Time frame: 90-days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Russia · 1 center
  • BELOOSTROV Clinic of High Technologies — Vsevolozhsk District

Identifiers

NCT: NCT06845306 · TBELOSTROVCOFHICG

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗