Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Colorectal Surgery

NCT ID: NCT06793280

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 562 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-06
• Study Completion Date: 2025-09-06

Brief Summary

Despite advancements in technology and improved surgical techniques, the occurrence of anastomotic leakage (AL) after colorectal surgery remains between 4% and 30%. AL is a feared complication associated with significant morbidity and mortality in colorectal surgery, with its causes being multifaceted. Inadequate blood supply to the intestines is believed to be a major contributor to its development. Various methods have been proposed to objectively assess intestinal perfusion beyond the subjective evaluation done by surgeons during surgery. However, these methods face challenges such as poor reproducibility and high costs, limiting their routine use. In recent years, indocyanine green (ICG) angiography has emerged as a tool for assessing organ perfusion in various medical scenarios. However, only one randomized clinical trial has been conducted regarding its use in evaluating colorectal surgery outcomes, which found that while ICG angiography sometimes led to additional bowel resection, it didn't significantly reduce the rate of anastomotic leaks compared to conventional methods. This could be due to the trial's small sample size, potentially reducing its statistical power. This study aims to investigate whether ICG angiography can lower the rate of anastomotic leaks during laparoscopic colorectal cancer surgery, while also examining its impact on resection margins, perioperative morbidity, and mortality rates.

A total of 561 subjects undergoing laparoscopic colorectal surgery for malignancy, will be randomized in 2 arms: A Study Group undergoing ICG angiography (i.e. colonic perfusion is intraoperatively assessed by ICG angiography and level of resection is selected based on the fluorescence) and a Control Group (i.e. resection is performed based on subjective judgment).

Conditions

Anastomotic Leak

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

ICG angiography

luorescence angiography is utilized to assess colonic resection margins and colorectal anastomosis, aiming to evaluate colonic blood flow. If the assessment indicates "insufficient" perfusion at the resection margin, the colon is resected once more to ensure satisfactory blood flow.

luorescence angiography is utilized to assess colonic resection margins and colorectal anastomosis, aiming to evaluate colonic blood flow. If the assessment indicates "insufficient" perfusion at the resection margin, the colon is resected once more to ensure satisfactory blood flow.

Colonic resection margins and colorectal anastomosis are intraoperatively assessed using fluorescence angiography to evaluate colonic perfusion. If perfusion at resection margin is considered "insufficient" the colon is resected again in order to obtain adequate perfusion.

Group Type: EXPERIMENTAL

intraoperative ICG angiography

Intervention Type: PROCEDURE

Intraoperative ICG angiography to evaluate colonic perfusion

No ICG angiography

Subjective visual measures are employed by the surgeon in order to determine anastomotic perfusion.

Group Type: ACTIVE_COMPARATOR

No intraoperative ICG angiography

Intervention Type: PROCEDURE

Visual evaluation of colonic perfusion

Interventions

intraoperative ICG angiography

Intraoperative ICG angiography to evaluate colonic perfusion

Intervention Type: PROCEDURE

No intraoperative ICG angiography

Visual evaluation of colonic perfusion

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age: 18-85 years
• Malignant colorectal tumors
• Elective surgery

Exclusion Criteria

• Abdomino-perineal resection
• Emergency procedures
• Conversion to open surgery
• No anastomosis
• Multifocal tumors
• Locally advanced cancer (T4)
• Distant metastases (M+)
• Major vasculopathies (previous PE, DVT, abdominal aorta surgery)
• ICG allergy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nuovo Ospedale dei Castelli

UNKNOWN

Sponsor Role: collaborator

San Giovanni Addolorata Hospital

OTHER

Sponsor Role: collaborator

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Lidia Castagneto Gissey

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lidia Castagneto Gissey

Roma, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Lidia Castagneto Gissey, MD, PhD

Role: CONTACT

lidia.castagnetogissey@uniroma1.it

3403497741

Giovanni Casella, MD, PhD

Role: CONTACT

giovanni.casella@uniroma1.it

Facility Contacts

Lidia Castagneto Gissey

Role: primary

lidia.castagnetogissey@uniroma1.it

3403497741

Other Identifiers

6608

Identifier Type: -

Identifier Source: org_study_id