The Prognosis Effect of Indocyanine Green (ICG) Fluorescence Guided Surgery on Disease-free Survival (DFS) of Stage III Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICG lymphangiography procedure.
- Who it may be relevant to
- Registry conditions: Colorectal Cancer Stage III. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Single Center Randomized Controlled Study of the Prognosis After Indocyanine Green Fluorescence-guided Radical Surgery in Colorectal Cancer Patients of Stage III
Overview
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
Interventions
- Procedure ICG lymphangiography procedure
All patients underwent standard complete mesocolic excision (CME) or total mesorectal excision (TME) with curable purpose using ICG lymphangiography procedure
Primary outcome measures
- Disease-free survival (DFS) rate [Time frame: From radical surgery to the end of follow-up ,up to 36 months]
Secondary outcome measures (3)
- the number of harvested lymph nodes [Time frame: From radical surgery to the end of perioperative period at 1 month]
- Postoperative complications [Time frame: From radical surgery to the end of perioperative period at 1 month]
- Overall survival rate [Time frame: From radical surgery to the end of follow-up ,up to 36 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Tongren Hospital — Changning
Identifiers
NCT: NCT06583564 · 2024-038-01