The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery

The Prognosis of Colorectal Cancer Patients After Indocyanine Green Fluorescence-guided Radical Surgery: a Retrospective Cohort Study

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 colorectal cancer patients following ICG fluorescence-guided surgery as compared to conventional surgery without the use of ICG Fluorescence imaging

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: conventional surgery; Procedure: ICG Guided surgery

• Study Type: Observational
• Enrollment (Actual): 235

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

all patients with newly diagnosed CRC who underwent CRC surgery between December 2016 and August 2021 in Shanghai Tongren hospital

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, -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; and
• severe mental disorder.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
conventional surgery; All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose.	Procedure: conventional surgery; All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose
Indocyanine green fluorescence-guided surgery; 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: conventional surgery; All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose; Procedure: ICG Guided surgery; In ICG guided surgery 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease-free survival(DFS)	the duration from radical surgery to the confirmation of recurrence or metastasis by regular or telephone follow-up	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of harvested lymph nodes	the number of harvested lymph nodes including positive and negative ones	1month

Collaborators and Investigators

• Sponsor: Shanghai Tong Ren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: July 13, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Colorectal cancer; prognosis; Indocyanine green
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2024-06-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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