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

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: conventional surgery; Procedure: ICG Guided surgery

• Registration Number: NCT06508541
• 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 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: 2024-07-13
• Study Start: 2024-07-15
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-18
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

(1)age > 18 years, (2)confirmed diagnosis of primary CRC, (3)preoperative tumor stage of cT1 to cT4, N-/+, M0 as determined by contrast-enhanced computed tomography (CT), (4) no distant metastasis, and (5)American Society of Anesthesiologists(ASA)Physical Status Classification score of 1, 2, or 3-

Exclusion Criteria

(1) history of previous colorectal surgery, emergent surgery, or palliative resection;(2)pregnancy or breastfeeding;(3) allergy or history of an adverse reaction to ICG; and (4) severe mental disorder.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
conventional surgery	conventional surgery	All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose.
Indocyanine green fluorescence-guided surgery	ICG 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
Indocyanine green fluorescence-guided surgery	conventional 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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
the number of harvested lymph nodes	1month	the number of harvested lymph nodes including positive and negative ones

Trial Locations

Locations (1)

Shanghai Tongren Hospital; 🇨🇳 Changning, Shanghai, China