Fluorescent dye mapping to guide lymph node removal in right-sided colon cancer surgery
Clinico-oncological Safety and Efficacy of Real-time Fluorescence Lymph Node Mapping (FLNM) in Laparoscopic and Robotic Right Hemicolectomy for Patients With Locally Advanced Right-sided Colon Cancer; Multicenter Phase II Open Labelled Randomized Controlled Trial
This study will test whether injecting indocyanine green to light up lymph nodes helps surgeons tailor D3 lymph node dissection for adults with locally advanced right-sided colon cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Ages | 19 Years to 85 Years |
| Sex | All |
| Sponsor | Pusan National University Yangsan Hospital Academic / other |
| Locations | 13 sites (Daegu and 12 other locations) |
| Trial ID | NCT07060443 on ClinicalTrials.gov |
What this trial studies
This multi-center phase 2 interventional study uses real-time indocyanine green (ICG) fluorescence lymph node mapping during right hemicolectomy to visualize individual lymphatic drainage and guide the extent of D3 lymphadenectomy, compared with standard surgery without ICG. Adult patients with clinically staged cT3-4 or node-positive right-sided colon cancer scheduled for planned right hemicolectomy will be enrolled at several university hospitals in Korea. The trial measures safety, technical feasibility, lymph node yield, and short-term oncologic outcomes to determine whether FLNM can safely tailor the extent of dissection. It aims to provide larger multi-center data to complement prior small single-center reports.
Who should consider this trial
Good fit: Adults aged 19–84 with locally advanced right-sided colon cancer (cT3-4N0 or any T with N1-2) scheduled for right hemicolectomy with planned D3 lymphadenectomy and ASA class I–III are ideal candidates.
Not a fit: Patients with distant or peritoneal metastases, emergency surgery needs, uncontrolled inflammatory bowel disease, iodine/ICG allergy, other active cancers, or significant hereditary/coagulopathy risks are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, FLNM could let surgeons remove the right amount of lymph tissue for each patient, potentially reducing unnecessary dissection while maintaining or improving cancer control.
How similar studies have performed: Small single-center studies have shown that ICG fluorescence can reliably visualize lymphatic drainage and increase lymph node detection, but large multicenter trials demonstrating oncologic benefit are still lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who over 19 years old, Under 85 years old 2. Patient with locally advanced right colon cancer requiring D3 lymphadenectomy 3. Colon cancer patients diagnosed with clinical stage cT3-4 N0 or cTany N1-2 before surgery 4. Patient with right-sided colon cancer located in the cecum, ascending colon, flexure colon, and proximal transverse colon. 5. Patients with American Society of Anesthesiology (ASA) I-III 6. Patients who agreed to the research purpose and voluntarily gave informed consent Exclusion Criteria: 1. Patients with a history of allergy or side effects to sodium iodine 2. Patients with colon cancer who have distant or peritoneal metastases 3. Patients requiring emergency surgery due to colon obstruction or colon perforation 4. Patients with inflammatory bowel disease not controlled by drug treatment 5. Patients with concurrent cancer in other areas other than colon cancer 6. Patients with a history of hereditary disease or coagulopathy at risk of bleeding 7. Women who are pregnant or may be pregnant and lactating women 8. Patients with chronic renal failure (e-GFR \< 15) or patients receiving dialysis at the time of screening 9. Patients diagnosed with liver failure or with decreased consciousness due to hepatic encephalopathy 10. Patients judged to have difficulty in smooth lymph perfusion due to heart disease (acute myocardial infarction, acute and chronic heart failure) within the past 6 months 11. Patients unable to undergo general anesthesia 12. Patients with American Society of Anesthesiology (ASA) IV or V 13. Patients who do not wish to participate in this study 14. Patients who are judged by the researcher to be unsuitable for participation in this clinical trial (Example: People with a life expectancy of less than 6 months, people expected to have low compliance with clinical trials, etc.)
Where this trial is running
Daegu and 12 other locations
- Keimyung University Dongsan Medical Center — Daegu, South Korea (Not_yet_recruiting)
- Kyungpook National University Chilgok Hospital — Daegu, South Korea (Recruiting)
- Chungnam National University Hospital — Daejeon, South Korea (Recruiting)
- National Cancer Center Korea — Goyang, South Korea (Not_yet_recruiting)
- Chonnam National University Hwasun Hospital — Hwasun, South Korea (Recruiting)
- Gachon University Gil Medical Center — Incheon, South Korea (Recruiting)
- Jeonbuk National University Hospital — Jeonju, South Korea (Recruiting)
- Seoul National University Bundang Hospital — Seongnam, South Korea (Not_yet_recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Korea University Guro Hospital — Seoul, South Korea (Not_yet_recruiting)
- Kyung Hee University Hospital — Seoul, South Korea (Not_yet_recruiting)
- St. Vincent's Hospital, The Catholic University of Korea — Suwon, South Korea (Recruiting)
- Pusan National University Yangsan Hospital — Yangsan, South Korea (Recruiting)
Study contacts
- Study coordinator: Principal Investigator, PhD
- Email: skm171@naver.com
- Phone: +82-10-7523-8056
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.