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

Last updated: April 8, 2025
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Colon Cancer

Colorectal Cancer

Treatment

ICG injection

Endoscopic Clipping

Clinical Study ID

NCT06714292
KSC-CRC-01
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 19years or more

  • With colonic neoplasm planning minimally invasive surgery

  • Need localization of lesion before surgery

Exclusion

Exclusion Criteria:

  • Planned total proctocolectomy

  • Contraindication of colonoscopy

  • On pregnancy or breast-feeding

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: ICG injection
Phase: 2
Study Start date:
December 10, 2024
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • National Cancer Center

    Goyang, Gyeonggi-do 10408
    Korea, Republic of

    Active - Recruiting

  • Seoul Boramae Medical Center

    Seoul, 07061
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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