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

NCT ID: NCT06508541

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 235 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2024-10-01

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

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

conventional surgery

All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose.

conventional surgery

Intervention Type: PROCEDURE

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

ICG Guided surgery

Intervention Type: PROCEDURE

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

conventional surgery

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

conventional surgery

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Tong Ren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Tongren Hospital

Changning, Shanghai Municipality, China

Countries

China

Other Identifiers

2024-06-001

Identifier Type: -

Identifier Source: org_study_id