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NCT07060443 | RECRUITING | Right Hemicolectomy

Fluorescence Lymph Node Mapping for Colon Cancer Surgery
Sponsor:

Pusan National University Yang Hospital

Information provided by (Responsible Party):

Gyung mo son

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.

Condition or disease

Right Hemicolectomy

Intervention/treatment

Indocyanine green (ICG) injection for intraoperative lymph node imaging

Standard Right Hemicolectomy (Non-ICG)

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 186 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : 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
Actual Study Start Date : 2025-07-23
Estimated Primary Completion Date : 2028-12-31
Estimated Study Completion Date : 2030-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.)
Fluorescence Lymph Node Mapping for Colon Cancer Surgery

Location Details

NCT07060443

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

Korea, Republic of,

Keimyung University Dongsan Medical Center

Daegu, Korea, Republic of,

RECRUITING

Korea, Republic of,

Kungpuka National University Chilgok Hospital

Daegu, Korea, Republic of,

RECRUITING

Korea, Republic of,

Chungnam National University Hospital

Daejeon, Korea, Republic of,

NOT YET RECRUITING

Korea, Republic of,

National Cancer Center Korea

Shake, Korea, Republic of,

RECRUITING

Korea, Republic of,

Chonnam National University Hwasun Hospital

Hwasun, Korea, Republic of,

RECRUITING

Korea, Republic of,

Gachon University Gil Medical Center

Incheon, Korea, Republic of,

RECRUITING

Korea, Republic of,

Jeonbuk National University Hospital

Jeonja, Korea, Republic of,

NOT YET RECRUITING

Korea, Republic of,

Seoul National University Bundang Hospital

Seongnam, Korea, Republic of,

RECRUITING

Korea, Republic of,

Asan Medical Center

Seoul, Korea, Republic of,

NOT YET RECRUITING

Korea, Republic of,

Korea University Teacher Hospital

Seoul, Korea, Republic of,

NOT YET RECRUITING

Korea, Republic of,

Kyung Hee University Hospital

Seoul, Korea, Republic of,

RECRUITING

Korea, Republic of,

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

Suwon, Korea, Republic of,

RECRUITING

Korea, Republic of,

Pusan National University Yang Hospital

The, Korea, Republic of,