The Prognosis Effect of Indocyanine Green (ICG) Fluorescence Guided Surgery on Disease-free Survival (DFS) of Stage III Colorectal Cancer

June 17, 2026 updated by: Shanghai Tong Ren Hospital

A Single Center Randomized Controlled Study of the Prognosis After Indocyanine Green Fluorescence-guided Radical Surgery in Colorectal Cancer Patients of Stage III

Previous studies of Indocyanine green (ICG) in colorectal surgery have focused on lymphatic mapping, lymph node detection, and the number of harvested lymph nodes. However, relatively few studies have evaluated the outcomes of this imaging technology, especially the prognosis following of colorectal cancer resection. The present study assessed the prognosis of stage III colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

192

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai Municipality
      • Changning, Shanghai Municipality, China, 200336
        • Shanghai Tongren Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age > 18 years,
  • confirmed diagnosis of primary CRC,
  • preoperative tumor stage of cT1 to cT4, N+, M0 as determined by contrast-enhanced computed tomography (CT),
  • no distant metastasis, and
  • American Society of Anesthesiologists(ASA)Physical Status Classification score of 1, 2, or 3

Exclusion Criteria:

  • history of previous colorectal surgery, emergent surgery, or palliative resection;
  • pregnancy or breastfeeding;
  • allergy or history of an adverse reaction to ICG
  • severe mental disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICG group
Approximately 0.3 ml of ICG dissolved in 2.5 mg/ml of sterile water was injected submucosally by the endoscopic doctors through colonoscopy at two points around the tumor.All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose using ICG lymphangiography procedure
Procedure: ICG lymphangiography procedure
All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose using ICG lymphangiography procedure
No Intervention: Non-ICG group
All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS) rate
Time Frame: From radical surgery to the end of follow-up ,up to 36 months
the rate of of no recurrence or metastasis after 3 years from radical surgery
From radical surgery to the end of follow-up ,up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of harvested lymph nodes
Time Frame: From radical surgery to the end of perioperative period at 1 month
the number of harvested lymph nodes of radical surgery
From radical surgery to the end of perioperative period at 1 month
Postoperative complications
Time Frame: From radical surgery to the end of perioperative period at 1 month
Postoperative complications ICG-related complications, surgery-related complications, and systemic complications. Postoperative complications were graded according to the Clavien-Dindo system
From radical surgery to the end of perioperative period at 1 month
Overall survival rate
Time Frame: From radical surgery to the end of follow-up ,up to 36 months
the rate of 3 years overall survival after radical surgery
From radical surgery to the end of follow-up ,up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Tong Ren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2024

Primary Completion (Estimated)

March 31, 2028

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

August 28, 2024

First Submitted That Met QC Criteria

September 2, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 17, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-038-01

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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