Actively Recruiting

Phase 2
Age: 19Years - 85Years
All Genders
NCT07060443

Fluorescence Lymph Node Mapping for Colon Cancer Surgery

Led by Pusan National University Yangsan Hospital · Updated on 2025-07-11

186

Participants Needed

13

Research Sites

283 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Fluorescence Lymph Node Mapping for Colon Cancer Surgery

Who Can Participate

Age: 19Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 19 to 85 years
  • Locally advanced right-sided colon cancer requiring D3 lymphadenectomy
  • Clinical stage cT3-4 N0 or cTany N1-2 diagnosed before surgery
  • Cancer located in the cecum, ascending colon, flexure colon, or proximal transverse colon
  • American Society of Anesthesiology (ASA) physical status I to III
  • Provided informed consent and agreed to participate in the research
Not Eligible

You will not qualify if you...

  • Allergy or side effects to sodium iodine
  • Presence of distant or peritoneal metastases from colon cancer
  • Need for emergency surgery due to colon obstruction or perforation
  • Uncontrolled inflammatory bowel disease
  • Presence of other cancers outside the colon
  • History of hereditary disease or bleeding disorders
  • Pregnancy, possible pregnancy, or lactation
  • Chronic renal failure with e-GFR less than 15 or receiving dialysis
  • Liver failure or decreased consciousness from hepatic encephalopathy
  • Recent heart disease causing lymph perfusion difficulty (within 6 months)
  • Unable to undergo general anesthesia
  • American Society of Anesthesiology (ASA) physical status IV or V
  • Declined participation in this study
  • Judged unsuitable by researchers due to low life expectancy or compliance issues

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 13 locations

1

Keimyung University Dongsan Medical Center

Daegu, South Korea

Not Yet Recruiting

2

Kyungpook National University Chilgok Hospital

Daegu, South Korea

Actively Recruiting

3

Chungnam National University Hospital

Daejeon, South Korea

Actively Recruiting

4

National Cancer Center Korea

Goyang, South Korea

Not Yet Recruiting

5

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Actively Recruiting

6

Gachon University Gil Medical Center

Incheon, South Korea

Actively Recruiting

7

Jeonbuk National University Hospital

Jeonju, South Korea

Actively Recruiting

8

Seoul National University Bundang Hospital

Seongnam, South Korea

Not Yet Recruiting

9

Asan Medical Center

Seoul, South Korea

Actively Recruiting

10

Korea University Guro Hospital

Seoul, South Korea

Not Yet Recruiting

11

Kyung Hee University Hospital

Seoul, South Korea

Not Yet Recruiting

12

St. Vincent's Hospital, The Catholic University of Korea

Suwon, South Korea

Actively Recruiting

13

Pusan National University Yangsan Hospital

Yangsan, South Korea

Actively Recruiting

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Research Team

P

Principal Investigator, PhD

CONTACT

P

Principal Investigator, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Fluorescence Lymph Node Mapping for Colon Cancer Surgery | DecenTrialz