Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Colorectal Surgery

Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Elective Colorectal Surgery: Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Anastomotic Leak
• Intervention / Treatment: Procedure: intraoperative ICG angiography; Procedure: No intraoperative ICG angiography

• Study Type: Interventional
• Enrollment (Actual): 562
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Italy
    • Roma, Italy, Italy, 00161
      • Lidia Castagneto Gissey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: intraoperative ICG angiography; Intraoperative ICG angiography to evaluate colonic perfusion
Active Comparator: No ICG angiography; Subjective visual measures are employed by the surgeon in order to determine anastomotic perfusion.	Procedure: No intraoperative ICG angiography; Visual evaluation of colonic perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anastomotic leak rate	90 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	90 days
Operative time	1 day
Modification in the level of resection margins (cm)	intraoperative
RCP levels (POD 3, 5)	5 days
Early complications (30 days)	30 days
Hospital re-admissions	30 days

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza
• Collaborators: San Giovanni Addolorata Hospital; Nuovo Ospedale dei Castelli

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: colorectal cancer; anastomotic leak; colorectal surgery
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Anastomotic Leak
• Other Study ID Numbers: 6608 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No