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

NCT06714292 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: KSC-CRC-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

tattooing; localization; colon cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  In operation

Secondary Outcomes (4)

• Reconfirmation Rate via Intraoperative Colonoscopy (%)

  In operation

• Total Operation Time (minutes)

  From start of operation to end of operation.

• Time Required for Endoscopic Marking Procedure (minutes)

  From identifying of tumor in colonoscopy to completing the clipping or injection of ICG

• Longitudinal Length of ICG Spread in the Control Group (mm)

  After resection of colon, in operation

Study Arms (2)

Clip group

EXPERIMENTAL

Patients who are underwent localization of colon lesion with fluorescent clip

Procedure: Endoscopic Clipping

ICG group

ACTIVE COMPARATOR

Patients who are underwent localization of colon lesion with ICG(indocyanine green) through tattooing method

Procedure: ICG injection

Interventions

Endoscopic Clipping PROCEDURE

localization of colon lesion with fluorescent clip

Clip group

ICG injection PROCEDURE

localization of colon lesion with ICG(indocyanine green) through endoscopic tattooing

Also known as: ICG tattooing

ICG group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 19years or more
• With colonic neoplasm planning minimally invasive surgery
• Need localization of lesion before surgery

You may not qualify if:

• Planned total proctocolectomy
• Contraindication of colonoscopy
• On pregnancy or breast-feeding

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (3)

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Seoul Boramae Medical Center

Seoul, 07061, South Korea

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Ji Won Park, M.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 3, 2024
• Study Start: December 10, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

KR (3)