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

Not Applicable

Not yet recruiting

• Conditions: Colorectal Cancer Stage III

• Registration Number: NCT06583564
• Lead Sponsor: Shanghai Tong Ren Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-28
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-02
• Last Update Submitted: 2024-09-02
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04
• Study Start: 2024-09-27
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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