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

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

Status

Enrolling by invitation

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06583564

Enrollment

192

Registered

2024-09-04

Start date

2024-09-27

Completion date

2028-03-31

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Stage III

Keywords

Colorectal cancer, Indocyanine green, prognosis

Brief summary

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

Interventions

PROCEDUREICG lymphangiography procedure

All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose using ICG lymphangiography procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Disease-free survival (DFS) rate	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

Secondary

Measure	Time frame	Description
the number of harvested lymph nodes	From radical surgery to the end of perioperative period at 1 month	the number of harvested lymph nodes of radical surgery
Postoperative complications	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
Overall survival rate	From radical surgery to the end of follow-up ,up to 36 months	the rate of 3 years overall survival after radical surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026