Fluorescent dye mapping to guide lymph node removal in right-sided colon cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Kyungpook National University Chilgok Hospital
  Daegu, South Korea Recruiting
• Chungnam National University Hospital
  Daejeon, South Korea 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
• Asan Medical Center
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Principal Investigator, PhD
• Email: skm171@naver.com
• Phone: +82-10-7523-8056

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.