Using a fluorescent clip to locate colon tumors during surgery
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
This study is testing a new fluorescent clip to see if it helps doctors find colon tumors more accurately during surgery compared to the traditional dye method.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 3 sites (Goyang, Gyeonggi-do and 2 other locations) |
| Trial ID | NCT06714292 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a fluorescent surgical marker clip for accurately localizing tumor sites in the colon during minimally invasive colorectal surgery. Participants will be randomly assigned to receive either the fluorescent clip or the traditional Indocyanine Green (ICG) dye for tumor marking. The study aims to compare the safety and effectiveness of the clip against the dye method, assessing any potential side effects associated with the clip. The goal is to improve localization techniques for better surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 years or older with colonic neoplasms who are planning minimally invasive surgery and require localization of the lesion.
Not a fit: Patients who are planning a total proctocolectomy or have contraindications for colonoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of tumor localization, leading to improved surgical outcomes for patients with colon cancer.
How similar studies have performed: While the use of fluorescent markers in surgery is gaining interest, this specific approach comparing a fluorescent clip to ICG dye is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Goyang, Gyeonggi-do and 2 other locations
- National Cancer Center — Goyang, Gyeonggi-do, Korea, Republic of (Recruiting)
- Seoul National University Hospital — Seoul, Korea, Republic of (Recruiting)
- Seoul Boramae Medical Center — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Ji Won Park, M.D. — Seoul National University Hospital
- Study coordinator: Youngjin Kim, Ph.D.
- Email: dudwls0819@naver.com
- Phone: +82-10-9600-9007
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.