Fluorescence Lymph Node Mapping for Colon Cancer Surgery

NCT07060443 | Recruiting Phase 2 DMC

• 1 other identifier: 13-2024-001
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 13

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.

Conditions

Right Hemicolectomy

Outcome Measures

Primary Outcomes (1)

• Pathological D3 lymph node metastasis detection rate

  From enrollment to within 4 weeks after surgery

Secondary Outcomes (16)

• Number of Harvest lymph nodes

  From enrollment to within 4 weeks after surgery.

• Lymph Node Ratio (LNR)

  From enrollment to within 4 weeks after surgery.

• Clinicopathological factors associated with FLNM success rate

  From enrollment to within 8 weeks after surgery.

• The bleeding rate due to damage to major blood vessels(SMA, SMV) during surgery

  From enrollment to within 1 week after surgery.

• Assessment of mesenteric dissection surface quality (3-point scale)

  From enrollment to within 1 week after surgery

Study Arms (2)

FLNM-guided Right Hemicolectomy

EXPERIMENTAL

FLNM-guided Right Hemicolectomy

Drug: Indocyanine green (ICG) injection for intraoperative lymph node imaging

Right Hemicolectomy

ACTIVE COMPARATOR

Standard Right Hemicolectomy without FLNM

Other: Standard Right Hemicolectomy (Non-ICG)

Interventions

Indocyanine green (ICG) injection for intraoperative lymph node imaging DRUG

Indocyanine Green (ICG) is used to guide the extent of D3 lymph node dissection during right hemicolectomy. After informed consent, participants randomized to the experimental group undergo bowel preparation and receive an endoscopic submucosal injection of ICG (0.25 mg/ml in saline) at two sites adjacent to the tumor one day prior to surgery. During surgery, near-infrared laparoscopic or robotic imaging systems detect the fluorescence emitted by ICG, guiding targeted D3 lymph node dissection at the origins of the ileocolic artery (ICA) and middle colic artery (MCA).

Also known as: Fluorescence-guided Lymph Node Mapping

FLNM-guided Right Hemicolectomy

Standard Right Hemicolectomy (Non-ICG) OTHER

Participants in the control group undergo standard right hemicolectomy with D3 lymph node dissection without the use of Indocyanine Green (ICG) or fluorescence imaging. The extent of dissection is determined by conventional anatomical landmarks and the surgeon's clinical judgment.

Also known as: Conventional Right Hemicolectomy

Right Hemicolectomy

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who over 19 years old, Under 85 years old
• Patient with locally advanced right colon cancer requiring D3 lymphadenectomy
• Colon cancer patients diagnosed with clinical stage cT3-4 N0 or cTany N1-2 before surgery
• Patient with right-sided colon cancer located in the cecum, ascending colon, flexure colon, and proximal transverse colon.
• Patients with American Society of Anesthesiology (ASA) I-III
• Patients who agreed to the research purpose and voluntarily gave informed consent

You may not qualify if:

• Patients with a history of allergy or side effects to sodium iodine
• Patients with colon cancer who have distant or peritoneal metastases
• Patients requiring emergency surgery due to colon obstruction or colon perforation
• Patients with inflammatory bowel disease not controlled by drug treatment
• Patients with concurrent cancer in other areas other than colon cancer
• Patients with a history of hereditary disease or coagulopathy at risk of bleeding
• Women who are pregnant or may be pregnant and lactating women
• Patients with chronic renal failure (e-GFR \< 15) or patients receiving dialysis at the time of screening
• Patients diagnosed with liver failure or with decreased consciousness due to hepatic encephalopathy
• 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
• Patients unable to undergo general anesthesia
• Patients with American Society of Anesthesiology (ASA) IV or V
• Patients who do not wish to participate in this study
• 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.)

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (13)

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

MeSH Terms

Interventions

Indocyanine Green; Injections

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Principal Investigator, PhD

CONTACT

+82-10-7523-8056; skm171@naver.com

Principal Investigator, PhD

CONTACT

+82-55-360-4835; skm171@naver.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: July 11, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (13)