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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLNM-guided Right Hemicolectomy | Experimental | FLNM-guided Right Hemicolectomy |
|
| Right Hemicolectomy | Active Comparator | Standard Right Hemicolectomy without FLNM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological D3 lymph node metastasis detection rate | From enrollment to within 4 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Harvest lymph nodes | Total lymph nodes, lymph nodes near tumor, D3 lymph nodes, ICA/RCA/MCA lymph nodes | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator, PhD | Contact | +82-10-7523-8056 | skm171@naver.com | |
| Principal Investigator, PhD | Contact | +82-55-360-4835 | skm171@naver.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Medical Center | Not yet recruiting | Daegu | South Korea |
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| 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. |
|
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| 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 | 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) | 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.
| From enrollment to within 1 week after surgery |
| Proximal and distal lengths(cm) | Proximal and distal resection lengths | From enrollment to within 1 week after surgery |
| Estimated Blood loss(ml) | On the day of surgery |
| Operation time(min) | 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. | 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. | 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. | 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.
| Assessed on the day of surgery |
| 3year disease-free survival rate | From enrollment to 3 years after surgery |
| overall survival rate | From enrollment to 5 years after surgery |
| local and systemic recurrence rate | From enrollment to 3 years after surgery |
| Surgeon perceptions of FLNM-guided D3 lymphadenectomy |
| - Before enrollment of the first subject (after IRB approval) - At the end of enrollment of all subjects |
| Kyungpook National University Chilgok Hospital | Recruiting | Daegu | South Korea |
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| Chungnam National University Hospital | Recruiting | Daejeon | South Korea |
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| National Cancer Center Korea | Not yet recruiting | Goyang | South Korea |
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| Chonnam National University Hwasun Hospital | Recruiting | Hwasun | South Korea |
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| Gachon University Gil Medical Center | Recruiting | Incheon | South Korea |
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| Jeonbuk National University Hospital | Recruiting | Jeonju | South Korea |
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| Seoul National University Bundang Hospital | Not yet recruiting | Seongnam | South Korea |
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| Asan Medical Center | Recruiting | Seoul | South Korea |
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| Korea University Guro Hospital | Not yet recruiting | Seoul | South Korea |
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| Kyung Hee University Hospital | Not yet recruiting | Seoul | South Korea |
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| St. Vincent's Hospital, The Catholic University of Korea | Recruiting | Suwon | South Korea |
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| Pusan National University Yangsan Hospital | Recruiting | Yangsan | South Korea |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| D007267 | Injections |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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