Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Total Number of Retrieved Lymph Nodes
研究概览
简要总结
Patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection ICG group and non-injection ICG group.
详细描述
Indocyanine Green Tracer is often applied in surgery for gastric cancer. Its application in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer 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 remnant gastric cancer. On the basis of more than 300 cases of laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer, 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 remnant gastric cancer, to guid the scope of laparoscopic lymph node dissection for remnant gastric cancer.
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
- •Remnant gastric cancer (cT1-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition)
- •(4) No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations (5) Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale (6) ASA (American Society of Anesthesiology) class I to III (7) Written informed consent
排除标准
- •Women during pregnancy or breast-feeding
- •Severe mental disorder
- •History of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy)
- •History of previous gastric surgery (including ESD/EMR for gastric cancer)
- •Rejection of laparoscopic resection
- •History of allergy to iodine agents
- •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 the past six months
- •History of unstable angina or myocardial infarction within past six months
- •History of continuous systematic administration of corticosteroids within one month
- •Requirement of simultaneous surgery for another disease
- •Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
- •FEV1<50% of the predicted values
- •Linitis plastica, Widespread
研究组 & 干预措施
ICG
Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group)
干预措施: Indocyanine Green Tracer (Drug)
Non-ICG
Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG 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: 30 days
Total Number of Retrieved Lymph Nodes
次要结局
- Postoperative recovery course(30 days)
- Lymph node noncompliance rate(30 days)
- Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group(30 days)
- Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate)(30 days)
- Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate)(30 days)
- Number of Metastasis Lymph Nodes(30 days)
- Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate)(30 days)
- Metastasis rate of lymph node(30 days)
- 3-year disease-free survival rate(3 years)
- Postoperative morbidity rate(30 days)
- Postoperative mortality rate(30 days)
- 3-year overall survival rate(3 years)
- 3-year recurrence pattern(3 years)
- Intraoperative situation(30 days)
研究者
Chang-Ming Huang, Prof.
Professor
Fujian Medical University