Fluorescence Lymph Node Mapping for Colon Cancer Surgery (CONSTELLARE)

Pusan National University Yangsan Hospital

Status and phase: Enrolling; Phase 2

Conditions: Right Hemicolectomy

Treatments: Drug: Indocyanine green (ICG) injection for intraoperative lymph node imaging; Other: Standard Right Hemicolectomy (Non-ICG)

Study type: Interventional

Funder types: Other

Identifiers

NCT07060443

13-2024-001

Details and patient eligibility

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.

Enrollment: 186 estimated patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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186 participants in 2 patient groups

FLNM-guided Right Hemicolectomy

Experimental group

Description:

FLNM-guided Right Hemicolectomy

Treatment:

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

Right Hemicolectomy

Active Comparator group

Description:

Standard Right Hemicolectomy without FLNM

Treatment:

Other: Standard Right Hemicolectomy (Non-ICG)