A Phase 2 interventional study of Endoscopic Clipping and ICG injection in Colon Cancer, sponsored by Seoul National University Hospital. Completed at 3 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Seoul National University Hospital · Phase 2, Interventional, and Other
The main questions the investigators aim to address are:
Can the clip safely and effectively localize tumor sites compared to ICG dye? What side effects or medical issues might arise with the use of the clip?
-Study Design Assignment
Participants will be randomly assigned to one of two groups:
The clip group: A fluorescent clip will be placed near the tumor. The dye group: ICG dye will be injected near the tumor.
Procedures Participants will undergo a colonoscopy to mark the tumor location before surgery using either the fluorescent clip or ICG dye.
Participants may qualify if:
They are 19 years or older. They are scheduled for minimally invasive colorectal surgery for a tumor or suspected tumor.
Exclusion Criteria
Participants cannot enroll if:
They have certain medical conditions, such as blood clotting disorders or allergies to metals or iodine.
They are pregnant or breastfeeding.
-Participant Role By participating, individuals will contribute to advancing research aimed at improving methods for tumor localization during surgery, potentially leading to enhanced surgical outcomes in the future.
For questions or concerns, participants are encouraged to contact the investigators or the research team.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 110 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who are underwent localization of colon lesion with fluorescent clip
Procedure: Endoscopic Clipping
Patients who are underwent localization of colon lesion with ICG(indocyanine green) through tattooing method
Procedure: ICG injection
localization of colon lesion with fluorescent clip
localization of colon lesion with ICG(indocyanine green) through endoscopic tattooing
Also known as: ICG tattooing
Success rate of localization
Accuracy of Identifying the Exact Tumor Location Experimental Group: Considered successful when the tumor can be observed through the applied clips using fluorescence imaging. Control Group: Considered successful when the ICG-tattooed tumor can be observed.
Time frame: In operation
Reconfirmation Rate via Intraoperative Colonoscopy (%)
The proportion of cases where intraoperative colonoscopy was performed.
Time frame: In operation
Total Operation Time (minutes)
The time from skin incision to skin closure.
Time frame: From start of operation to end of operation.
Time Required for Endoscopic Marking Procedure (minutes)
The time from identifying the tumor to completing the attachment of all required clips for marking the tumor or completing the injection of ICG.
Time frame: From identifying of tumor in colonoscopy to completing the clipping or injection of ICG
Longitudinal Length of ICG Spread in the Control Group (mm)
In ICG group, measure the length of tattooed area using a disposable paper ruler on the serosa side of colon.
Time frame: After resection of colon, in operation
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital