Fluorescence Lymph Node Mapping for Colon Cancer Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-23

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Right Hemicolectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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FLNM-guided Right Hemicolectomy

Group Type EXPERIMENTAL

Indocyanine green (ICG) injection for intraoperative lymph node imaging

Intervention Type 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).

Right Hemicolectomy

Standard Right Hemicolectomy without FLNM

Group Type ACTIVE_COMPARATOR

Standard Right Hemicolectomy (Non-ICG)

Intervention Type 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.

Interventions

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Indocyanine green (ICG) injection for intraoperative lymph node imaging

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).

Intervention Type DRUG

Standard Right Hemicolectomy (Non-ICG)

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.

Intervention Type OTHER

Other Intervention Names

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Fluorescence-guided Lymph Node Mapping Conventional Right Hemicolectomy

Eligibility Criteria

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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.)

Minimum Eligible Age

19 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No