Comparison of Submucosal and Subserosal Approaches Toward Optimized Indocyanine Green Tracer-Guided Laparoscopic Lymphadenectomy for Patients With Gastric Cancer: The FUGES-019 Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Total Number of Retrieved Lymph Nodes
研究概览
简要总结
The purpose of this study was to evaluate whether submucosal or subserous injection of indocyanine green during laparoscopic lymphadenectomy for patients with gastric cancer was different. The patients with gastric adenocarcinoma (cT1-4a, N0/+, M0) were studied.
详细描述
In recent years, with the successful application of ICG (indocyanine green) fluorescence imaging technology in laparoscopic equipment, scholars have found that ICG near-infrared imaging has better tissue penetration and can better identify lymph nodes in hypertrophic adipose tissue than other dyes under visible light, which makes ICG fluorescence imaging guide laparoscopic radical resection of gastric cancer lymph node dissection has become a new exploration direction. ICG near-infrared imaging technology has important research value, good application prospects, and broad development space in laparoscopic radical resection of gastric cancer. However, at present, the application of ICG near-infrared imaging technology in laparoscopic radical resection of gastric cancer is still in the exploratory stage, and there is no unified standard. Therefore, in the world, there is still a lack of high-level evidence-based evidence of large-sample prospective randomized controlled trials to evaluate the effectiveness, safety, and feasibility of submucosal or subserous injection of ICG in guiding laparoscopic D2 resection of gastric cancer. The investigator first carried out this study in the world to evaluate the lymph node dissection and perioperative safety of gastric cancer patients who received a submucosal injection of ICG and subserous injection of ICG during laparoscopic radical gastrectomy in the same period, to promote the standardized development of ICG near-infrared imaging in laparoscopic radical gastrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Although it was not feasible to blind the surgeons and participants, the pathologists were unaware of the intervention received by the patients. The researcher performing the statistical analyses was blinded to the patient group allocation.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Subserosal injection of indocyanine green tracer group
Subserosal injection of indocyanine green, with a concentration of 0.5 mg /ml, 6 points along the lesser and greater curvature of the stomach, 1.5 ml for each point.
干预措施: Subserosa injection of indocyanine green (Drug)
Submucosal injection of indocyanine green tracer group
Submucosal injection of indocyanine green, with a concentration of 1.25mg /ml, four points around the primary tumor, each point 0.5 ml.
干预措施: submucosal injection of indocyanine green (Drug)
结局指标
主要结局
Total Number of Retrieved Lymph Nodes
时间窗: One month after surgery
Total Number of Retrieved Lymph Nodes
次要结局
- Metastasis rate of lymph node(One month after surgery)
- Relationship between fluorescent lymph nodes and positive lymph nodes in groups A and B (true positive rate)(One month after surgery)
- Relationship between fluorescent lymph nodes and negative lymph nodes in groups A and B (false positive rate)(One month after surgery)
- Relationship between non-fluorescent and negative lymph nodes in groups A and B (true negative rate)(One month after surgery)
- Time to first ambulation(30 days)
- Time to first liquid diet(30 days)
- Morbidity rates(30 days)
- Time to first flatus(30 days)
- 3-year disease free survival rate(36 months)
- 3-year recurrence pattern(36 months)
- The variation of weight(3, 6, 9 and 12 months)
- Intraoperative morbidity rates(1 day)
- The variation of hemoglobin(Preoperative 3 days and postoperative 1, 3, and 5 days)
- The Surgery Task Load Index (SURG-TLX)(1 day)
- 3-year overall survival rate(36 months)
- Total number of fluorescent lymph nodes in groups A and B(One month after surgery)
- Relationship between non-fluorescent lymph nodes and positive lymph nodes in groups A and B (false negative rate)(One month after surgery)
- Number of Metastasis Lymph Nodes(One month after surgery)
- Mortality rates(30 days)
- The variation of white blood cell count(Preoperative 3 days and postoperative 1, 3, and 5 days)
- The variation of C-reactive protein(Preoperative 3 days and postoperative 1, 3, and 5 days)
- Modified EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT14)(30 days)
- Time to first soft diet(30 days)
- Duration of postoperative hospital stay(30 days)
- The variation of BMI in kg/m^2(3, 6, 9 and 12 months)
- Lymph node noncompliance rate(1 day)
研究者
Chang-Ming Huang, Prof.
Director, Head of Department of Gastric Surgery, Principal Investigator, Clinical Professor
Fujian Medical University