Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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 is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma（cT1-4a, N-/+, M0）.
详细描述
Indocyanine Green Tracer is often applied in surgery for early gastric adenocarcinoma. Its application in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma is at the stage of cases accumulation, method studying and clinical research. There is no prospective studies to identify the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma.
On the basis of more than 3000 cases of laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma, we want to apply the Indocyanine Green Tracer, a cheap, easy to operate and no radiation pollution way, to predict the positive lymph nodes in gastric adenocarcinoma, to guid the scope of laparoscopic lymph node dissection for gastric adenocarcinoma.
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
- None
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
- •Age from 18 to 75 years
- •Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- •clinical stage tumor 1-4a (cT1-4a), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- •No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
- •Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- •American Society of Anesthesiology score (ASA) class I, II, or III
- •Written informed consent
排除标准
- •Women during pregnancy or breast-feeding
- •Severe mental disorder
- •History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- •History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- •Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- •History of other malignant disease within past five years
- •History of previous neoadjuvant chemotherapy or radiotherapy
- •History of unstable angina or myocardial infarction within past six months
- •History of cerebrovascular accident within past six months
- •History of continuous systematic administration of corticosteroids within one month
- •Requirement of simultaneous surgery for other disease
- •Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- •FEV1<50% of predicted values
- •Diffuse; widespread; plastica
研究组 & 干预措施
Indocyanine Green Tracer
Indocyanine Green Tracer will be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
干预措施: Indocyanine Green Tracer (Drug)
No Indocyanine Green Tracer
Indocyanine Green Tracer will not be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
干预措施: Indocyanine Green Tracer (Drug)
结局指标
主要结局
Total Number of Retrieved Lymph Nodes
时间窗: 14 days
Compare total number of retrieved lymph nodes in both group.
次要结局
- False positive rate(14 days)
- Negative rate(14 days)
- False negative rate(14 days)
- Number of Metastasis Lymph Nodes(14 days)
- Metastasis rate of lymph node(14 days)
- Morbidity and mortality rates(30 days)
- 3-year disease free survival rate(36 months)
- 3-year recurrence pattern(36 months)
- Incision length(1 day)
- The results of endoscopy(3, 6, 9 and 12 months)
- The variation of body temperature(8 days)
- The rate of fluorescence(14 days)
- Positive rate(14 days)
- The variation of cholesterol(3, 6, 9 and 12 months)
- The variation of album(3, 6, 9 and 12 months)
- 5-year recurrence pattern(60 months)
- Postoperative recovery course(10 days)
- Operation time(1 day)
- The variation of weight(3, 6, 9 and 12 months)
- Intraoperative blood loss(1 day)
- Conversive rate(1 day)
- Intraoperative morbidity rates(1 day)
- The variation of white blood cell count(Preoperative 3 days and postoperative 1, 3, and 5 days)
- The variation of hemoglobin(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)
- The variation of prealbumin(Preoperative 3 days and postoperative 1, 3, and 5 days)
- 3-year overall survival rate(36 months)
- 5-year overall survival rate(60 months)
- 5-year disease free survival rate(60 months)
研究者
Chang-Ming Huang, Prof.
Clinical Professor
Fujian Medical University Union Hospital