A Phase 2 interventional study of Indocyanine green (ICG) injection for intraoperative lymph node imaging and Standard Right Hemicolectomy (Non-ICG) in Right Hemicolectomy, sponsored by Pusan National University Yangsan Hospital. Recruiting at 13 sites in South Korea. Open to participants aged 19 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-07-11.
Sponsored by Pusan National University Yangsan Hospital · Phase 2, Interventional, and Diagnostic
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.
Pusan National University Yangsan Hospital is the lead sponsor of 106 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
FLNM-guided Right Hemicolectomy
Drug: Indocyanine green (ICG) injection for intraoperative lymph node imaging
Standard Right Hemicolectomy without FLNM
Other: Standard Right Hemicolectomy (Non-ICG)
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
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
Pathological D3 lymph node metastasis detection rate
Time frame: From enrollment to within 4 weeks after surgery
Number of Harvest lymph nodes
Total lymph nodes, lymph nodes near tumor, D3 lymph nodes, ICA/RCA/MCA lymph nodes
Time frame: From enrollment to within 4 weeks after surgery.
Lymph Node Ratio (LNR)
LNR (lymph node ratio) = number of metastatic lymph nodes / total number of lymph nodes
Time frame: From enrollment to within 4 weeks after surgery.
Clinicopathological factors associated with FLNM success rate
Gender, age, BMI, pathological stage, tumor size, colon obstruction, etc
Time frame: From enrollment to within 8 weeks after surgery.
The bleeding rate due to damage to major blood vessels(SMA, SMV) during surgery
Time frame: From enrollment to within 1 week after surgery.
Assessment of mesenteric dissection surface quality (3-point scale)
A 3-point scoring system will be used to evaluate the quality of the mesenteric dissection surface following surgery. A higher score reflects a well-preserved mesenteric dissection surface with minimal or no damage. * 3 points: Complete mesenteric dissection (the dissection surface is intact, with no visible damage, and the peritoneal surface is well preserved) * 2 points: Nearly complete mesenteric dissection (the dissection surface shows some damage, but there is no exposure of tumor tissue) * 1 point: Incomplete mesenteric dissection (the dissection surface is damaged, with exposure of tumor tissue within the colonic wall.)
Time frame: From enrollment to within 1 week after surgery
Proximal and distal lengths(cm)
Proximal and distal resection lengths
Time frame: From enrollment to within 1 week after surgery
Estimated Blood loss(ml)
Time frame: On the day of surgery
Operation time(min)
Time frame: On the day of surgery
Complications
This outcome measure assesses postoperative complications occurring within 30 days after surgery. Complications are classified according to the Clavien-Dindo classification system, which grades adverse events based on their severity and the type of intervention required. Trained clinical staff will record and categorize complications during the postoperative follow-up period.
Time frame: Within 30 days after surgery
Readmission
This outcome measure records whether patients are readmitted to the hospital within 30 days after surgery. In cases of readmission, the reason for readmission will be documented, including complications, treatment-related issues, or other causes as determined by clinical evaluation.
Time frame: Within 30 Days After Surgery
Reoperation
This outcome measure records whether patients undergo reoperation within 30 days after the initial surgery. The reasons for reoperation, such as complications or surgical site issues, will be documented based on clinical evaluation.
Time frame: Within 30 Days After Surgery
Completeness score of D3 lymph node dissection (3-point scale)
A 3-point scoring system will be used intraoperatively to assess the completeness of D3 lymph node dissection using real-time fluorescence imaging. Higher scores indicate a more complete lymph node dissection. * 1 point: Residual fluorescent lymph nodes are present in the D3 area (justification required). * 2 points: Residual fluorescent lymph nodes are present but resection is deemed unnecessary by the surgeon (e.g., outside D3 area; justification required). * 3 points: No residual fluorescent lymph nodes remain in the D3 area.
Time frame: Assessed on the day of surgery
3year disease-free survival rate
Time frame: From enrollment to 3 years after surgery
overall survival rate
Time frame: From enrollment to 5 years after surgery
local and systemic recurrence rate
Time frame: From enrollment to 3 years after surgery
Surgeon perceptions of FLNM-guided D3 lymphadenectomy
* A custom survey developed by the research team will assess surgeons' perceptions of the usefulness, safety, and potential future application of Fluorescence lymph node mapping (FLNM) guided D3 lymphadenectomy in colorectal cancer surgery. The survey includes Likert-type questions (e.g., "Strongly agree" to "Strongly disagree") and multiple-choice items (e.g., "For which patients is FLNM used?"). * Responses will be reported as the proportion of participants selecting each option for key questions, such as: * Is FLNM helpful for determining the lymph node dissection range? * Do you plan to use FLNM in future surgeries? * Do you believe FLNM helps reduce complications? * For which patient groups is FLNM currently used? * The survey will be conducted at two time points: (1) before enrollment of the first subject (after IRB approval), and (2) after enrollment of all subjects has been completed.
Time frame: - Before enrollment of the first subject (after IRB approval) - At the end of enrollment of all subjects
Plan to share: No
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Pusan National University Yangsan Hospital