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

Seoul National University

Status and phase: Active, not recruiting; Phase 2

Conditions: Colon Cancer

Treatments: Procedure: ICG injection; Procedure: Endoscopic Clipping

Study type: Interventional

Funder types: Other

Identifiers

NCT06714292

KSC-CRC-01

Details and patient eligibility

About

• 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Clip group

Experimental group

Description:

Patients who are underwent localization of colon lesion with fluorescent clip

Treatment:

Procedure: Endoscopic Clipping

ICG group

Active Comparator group

Description:

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

Treatment:

Procedure: ICG injection