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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 13
- 主要终点
- Pathological D3 lymph node metastasis detection rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.)
研究组 & 干预措施
FLNM-guided Right Hemicolectomy
FLNM-guided Right Hemicolectomy
干预措施: Indocyanine green (ICG) injection for intraoperative lymph node imaging (Drug)
Right Hemicolectomy
Standard Right Hemicolectomy without FLNM
干预措施: Standard Right Hemicolectomy (Non-ICG) (Other)
结局指标
主要结局
Pathological D3 lymph node metastasis detection rate
时间窗: From enrollment to within 4 weeks after surgery
次要结局
- Number of Harvest lymph nodes(From enrollment to within 4 weeks after surgery.)
- Lymph Node Ratio (LNR)(From enrollment to within 4 weeks after surgery.)
- Clinicopathological factors associated with FLNM success rate(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)(From enrollment to within 1 week after surgery)
- Proximal and distal lengths(cm)(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(Within 30 days after surgery)
- Readmission(Within 30 Days After Surgery)
- Reoperation(Within 30 Days After Surgery)
- Completeness score of D3 lymph node dissection (3-point scale)(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)
研究者
Gyung Mo Son
Professor of Surgery
Pusan National University Yangsan Hospital