NCT06714292

Fluorescent Approach for Refined Endoscopic Marking With Clip Localization and Identification Procedure

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

* 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.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Clipping	localization of colon lesion with fluorescent clip
PROCEDURE	ICG injection	localization of colon lesion with ICG(indocyanine green) through endoscopic tattooing

Timeline

• Start date: 2024-12-10
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2024-12-03
• Last updated: 2025-11-19

Locations

3 sites across 1 country: South Korea