Evaluation of Colonic Perfusion by Indocyanine Green Angiography During Colorectal Surgery

NCT06793280 | Recruiting DMC

• 1 other identifier: 6608
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 1

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

Keywords

anastomotic leak; colorectal surgery; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Anastomotic leak rate

  90 days

Secondary Outcomes (6)

• Modification in the level of resection margins (cm)

  intraoperative

• RCP levels (POD 3, 5)

  5 days

• Early complications (30 days)

  30 days

• Mortality

  90 days

• Hospital re-admissions

  30 days

Study Arms (2)

ICG angiography

EXPERIMENTAL

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

No ICG angiography

ACTIVE COMPARATOR

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

Procedure: No intraoperative ICG angiography

Interventions

intraoperative ICG angiography PROCEDURE

Intraoperative ICG angiography to evaluate colonic perfusion

ICG angiography

No intraoperative ICG angiography PROCEDURE

Visual evaluation of colonic perfusion

No ICG angiography

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Nuovo Ospedale dei Castelli: collaborator
• San Giovanni Addolorata Hospital: collaborator

Study Sites (1)

Lidia Castagneto Gissey

Roma, Italy, 00161, Italy

RECRUITING

MeSH Terms

Conditions

Anastomotic Leak; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Lidia Castagneto Gissey, MD, PhD

CONTACT

3403497741; lidia.castagnetogissey@uniroma1.it

Giovanni Casella, MD, PhD

CONTACT

giovanni.casella@uniroma1.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: An interim analysis incoroporating a futility assessment is designed to assess whether this trial is likely to meet its objective before its completion

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: January 27, 2025
• Study Start: May 6, 2023
• Primary Completion: May 6, 2025
• Study Completion: September 6, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)