Fluorescence Lymph Node Mapping for Colon Cancer Surgery

Официальное название

Clinico-oncological Safety and Efficacy of Real-time Fluorescence Lymph Node Mapping (FLNM) in Laparoscopic and Robotic Right Hemicolectomy for Patients With Locally Advanced Right-sided Colon Cancer; Multicenter Phase II Open Labelled Randomized Controlled Trial

Обзор

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.

Вмешательства

• Препарат 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
• Другое 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.

Первичные конечные точки

• Pathological D3 lymph node metastasis detection rate [Срок оценки: From enrollment to within 4 weeks after surgery]

Вторичные конечные точки (12)

• Number of Harvest lymph nodes [Срок оценки: From enrollment to within 4 weeks after surgery.]
• Lymph Node Ratio (LNR) [Срок оценки: From enrollment to within 4 weeks after surgery.]
• Clinicopathological factors associated with FLNM success rate [Срок оценки: From enrollment to within 8 weeks after surgery.]
• The bleeding rate due to damage to major blood vessels(SMA, SMV) during surgery [Срок оценки: From enrollment to within 1 week after surgery.]
• Assessment of mesenteric dissection surface quality (3-point scale) [Срок оценки: From enrollment to within 1 week after surgery]
• Proximal and distal lengths(cm) [Срок оценки: From enrollment to within 1 week after surgery]
• Estimated Blood loss(ml) [Срок оценки: On the day of surgery]
• Operation time(min) [Срок оценки: On the day of surgery]
• Complications [Срок оценки: Within 30 days after surgery]
• Readmission [Срок оценки: Within 30 Days After Surgery]
• Reoperation [Срок оценки: Within 30 Days After Surgery]
• Completeness score of D3 lymph node dissection (3-point scale) [Срок оценки: Assessed on the day of surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

South Korea · 13 центров

• Keimyung University Dongsan Medical Center — Daegu
• Kyungpook National University Chilgok Hospital — Daegu
• Chungnam National University Hospital — Daejeon
• National Cancer Center Korea — Goyang
• Chonnam National University Hwasun Hospital — Hwasun
• Gachon University Gil Medical Center — Incheon
• Jeonbuk National University Hospital — Jeonju
• Seoul National University Bundang Hospital — Seongnam
• … и ещё 5 центров

Идентификаторы

NCT: NCT07060443 · 13-2024-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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