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

Shanghai Jiao Tong University

Status: Completed

Conditions: Colorectal Cancer

Treatments: Procedure: ICG Guided surgery; Procedure: conventional surgery

Study type: Observational

Funder types: Other

Identifiers

NCT06508541

2024-06-001

Details and patient eligibility

About

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

Enrollment: 235 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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, -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.

Trial design

235 participants in 2 patient groups

conventional surgery

Description:

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

Treatment:

Procedure: conventional surgery

Indocyanine green fluorescence-guided surgery

Description:

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

Treatment:

Procedure: conventional surgery

Procedure: ICG Guided surgery