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

Vadim Kuznetsov

Status and phase: Not yet enrolling; Phase 3

Conditions: Colo-rectal Cancer; Colonic Neoplasms Malignant

Treatments: Other: Conventional Bowel Anastomosis group; Drug: ICG-guided bowel perfusion assessment

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06845306

TBELOSTROVCOFHICG

Details and patient eligibility

About

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.

Enrollment: 1,268 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

1,268 participants in 2 patient groups, including a placebo group

The ICG group

Active Comparator group

Description:

The ICG group, where, before creating the anastomosis, intestinal blood flow will be assessed using quantitative near-infrared fluorescence imaging using indocyanine green.

Treatment:

Drug: ICG-guided bowel perfusion assessment

The control group

Placebo Comparator group

Description:

The control group, where before the creation of the anastomosis, the intestinal blood flow will not be assessed.

Treatment:

Other: Conventional Bowel Anastomosis group