A Single Center Randomized Controlled Study of the Prognosis After Indocyanine Green Fluorescence-guided Radical Surgery in Colorectal Cancer Patients of Stage III
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 192
- Locations
- 1
- Primary Endpoint
- Disease-free survival (DFS) rate
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
ICG 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: ICG lymphangiography procedure (Procedure)
Non-ICG group
All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose.
Outcomes
Primary Outcomes
Disease-free survival (DFS) rate
Time Frame: 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 Outcomes
- the number of harvested lymph nodes(From radical surgery to the end of perioperative period at 1 month)
- Postoperative complications(From radical surgery to the end of perioperative period at 1 month)
- Overall survival rate(From radical surgery to the end of follow-up ,up to 36 months)