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Trial Title:
The Prognosis Effect of Indocyanine Green (ICG) Fluorescence Guided Surgery on Disease-free Survival (DFS) of Stage III Colorectal Cancer
NCT ID:
NCT06583564
Condition:
Colorectal Cancer Stage III
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Colorectal cancer
Indocyanine green
prognosis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
ICG lymphangiography procedure
Description:
All patients underwent standard complete mesocolic excision (CME) or total mesorectal
excision (TME) with curable purpose using ICG lymphangiography procedure
Arm group label:
ICG group
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
Criteria for 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, 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Tongren Hospital
Address:
City:
Changning
Zip:
200336
Country:
China
Start date:
September 27, 2024
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Shanghai Tong Ren Hospital
Agency class:
Other
Source:
Shanghai Tong Ren Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06583564
