Fluorescent Approach for Refined Endoscopic Marking With Clip Localization and Identification Procedure
NCT ID: NCT06714292
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2024-12-10
2026-01-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Clip group
Patients who are underwent localization of colon lesion with fluorescent clip
Endoscopic Clipping
localization of colon lesion with fluorescent clip
ICG group
Patients who are underwent localization of colon lesion with ICG(indocyanine green) through tattooing method
ICG injection
localization of colon lesion with ICG(indocyanine green) through endoscopic tattooing
Interventions
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Endoscopic Clipping
localization of colon lesion with fluorescent clip
ICG injection
localization of colon lesion with ICG(indocyanine green) through endoscopic tattooing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With colonic neoplasm planning minimally invasive surgery
* Need localization of lesion before surgery
Exclusion Criteria
* Contraindication of colonoscopy
* On pregnancy or breast-feeding
19 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Ji Won Park, M.D.
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
Seoul Boramae Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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KSC-CRC-01
Identifier Type: -
Identifier Source: org_study_id
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