NCT07060443 Fluorescence Lymph Node Mapping for Colon Cancer Surgery
| NCT ID | NCT07060443 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Pusan National University Yangsan Hospital |
| Condition | Right Hemicolectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 186 participants |
| Start Date | 2025-07-23 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 186 participants in total. It began in 2025-07-23 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Fluorescence-guided surgery using indocyanine green can visualize the complex and diverse lymph node drainage structures for each patient and help determine the extent of dissection of the D3 lymph node tailored to the patient. However, since fluorescence lymph node mapping (FLNM) is still being conducted only at some institutions for research purposes and is limited to reporting the results of small-scale studies of patients, a large-scale multi-center study was conducted to verify the clinical-oncological effects of FLNM. Research is needed. Therefore, this study used real-time fluorescence lymph node mapping (FLNM) to determine the extent of D3 lymph node dissection when performing right hemicolectomy and D3 lymph node dissection in patients with locally advanced right-sided colon cancer and to safely remove extensive lymph nodes. We aim to evaluate whether the dissection procedure is safe and beneficial in terms of clinical oncology.
Eligibility 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.)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07060443 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 85 Years, studying Right Hemicolectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07060443 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07060443 currently recruiting?
Yes, NCT07060443 is actively recruiting participants. Contact the research team at skm171@naver.com for enrollment information.
Where is the NCT07060443 trial being conducted?
This trial is being conducted at Daegu, South Korea, Daegu, South Korea, Daejeon, South Korea, Goyang, South Korea and 9 additional locations.
Who is sponsoring the NCT07060443 clinical trial?
NCT07060443 is sponsored by Pusan National University Yangsan Hospital. The trial plans to enroll 186 participants.