Endoscopic Clipping
Procedurelocalization of colon lesion with fluorescent clip
NCT Number: NCT06714292
* Title of the Study Testing a Fluorescent Surgical Marker Clip for Tumor Localization in Minimally Invasive Colorectal Surgery * Purpose of the Study This study aims to determine if a fluorescent surgical marker clip can accurately and safely localize tumor locations in the colon during minimally invasive colorectal surgery. The study will compare the effectiveness of this clip to the current method using a dye called Indocyanine Green (ICG).
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.
* Follow-Up Participants will attend follow-up visits after surgery to monitor for any side effects or complications. * Eligibility Inclusion Criteria
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.
This study is active but is not currently recruiting participants.
Notify Me19 year and older
All sexes
Interventional
Phase 2
National Cancer Center, Goyang-si, Gyeonggi-do, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
localization of colon lesion with fluorescent clip
localization of colon lesion with ICG(indocyanine green) through endoscopic tattooing
Other names: ICG tattooing
Time frame: In operation
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
The proportion of cases where intraoperative colonoscopy was performed.
Time frame: From start of operation to end of operation.
The time from skin incision to skin closure.
Time frame: From identifying of tumor in colonoscopy to completing the clipping or injection of ICG
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: After resection of colon, in operation
In ICG group, measure the length of tattooed area using a disposable paper ruler on the serosa side of colon.
Seoul National University Hospital
Other
Efficacy and Safety of Fluorescent Surgical Marker Clip for Tumor Localization in Laparoscopic Colorectal Surgery for Colorectal Cancer Patients : Multi-center, Randomized, Single-blind, Prospective, Non-Inferiority Trial
Acronym: FLARECLIP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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