Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- 3-year disease free survival rate
研究概览
简要总结
Patients with locally advanced gastric adenocarcinoma (cT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic D2 lymph node dissection for gastric cancer after neoadjuvant chemotherapy by comparing injection ICG group and non-injection ICG group
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
- 是
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
- •cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition
- •No distant metastasis, no invasion of pancreas, spleen or other adjacent organs in the preoperative examinations
- •Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
- •ASA (American Society of Anesthesiology) score I to III
- •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)
- •History of previous gastric surgery (including ESD/EMR for gastric cancer)
- •Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging.
- •Other malignant disease within the past 5 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 for simultaneous surgery for other disease
- •Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- •FEV1 (forced expiratory volume in one second)<50% of predicted values
- •Diffuse invasive gastric cancer
- •Preoperatively, tumors involving the squamocolumnar junction or duodenum were confirmed
- •A history of iodine allergy
- •Refuse laparoscopic surgery
研究组 & 干预措施
Group A
Laparoscopic gastrectomy group with the use of near-infrared imaging (ICG group)
干预措施: Indocyanine Green (Drug)
Group B
Laparoscopic gastrectomy group without the use of near-infrared imaging (Non-ICG group)
干预措施: Indocyanine Green (Drug)
结局指标
主要结局
3-year disease free survival rate
时间窗: 3 years
Disease-free survival is calculated from the day of surgery to the day of recurrence (When the specific date of recurrence of the tumor is unknown, the ending point is the date of death due to tumor causes). In the event that neither death nor recurrence of the tumor are observed, the end point is the final date that a patient is confirmed as relapse-free.
次要结局
- Total number of retrieved lymph nodes(30 days)
研究者
Chang-Ming Huang, Prof.
Professor
Fujian Medical University