Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in 3D Plus Ultra High Resolution Laparoscopic Gastrectomy With Lymph Node Dissection for Locally Advanced Gastric Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 702
- 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 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.
详细描述
- Research purpose: 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 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.
- Research design: Prospective, single-center, randomized controlled, open-control, parallel assignment, superiority test.
2.1 Case group Group A (Study Group 1, 234 cases): ICG near-infrared imaging tracing in 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection; Group B (Study Group 2, 234 cases): ICG near-infrared imaging tracing in ultra high resolution laparoscopic gastrectomy with lymph node dissection; Group C (Control Group 2, 234 cases) 3D laparoscopic gastrectomy with lymph node dissection
2.2 Estimate Sample Size The three-year disease-free survival (DFS) was the main effectiveness evaluation index in this study. The study implemented a superiority test (unilateral), assuming that both the study group's three-year DFS would be better than that of control group, according to previous research results of laparoscopic surgery for locally advanced GC in which the three-year DFS was 65.2%; therefore, the 3-year DFS of the control group would be 65.2%, assuming that the 3-year DFS of the experimental group could be increased by 12% to 77.2%. With an inspection level 0.0125 (unilateral) and an inspection efficiency of 0.8 and using PASS 11 log-rank tests (Lakatos) [Proportion surviving] the calculated sample size was N=211; namely, each group needed 211 people, considering cases of possible exclusion and loss to follow-up (10% drop out rate). The final sample size for each group was 234 cases, for a total of 702 cases.
2.3 randomization After laparoscopic exploration and confirmation that the cases complied with the standards, they were included in the randomized groups in this study. SAS 9.2 was used to produce a serial number ranging from 0001 - 702 corresponding to the treatment allocation, which was reserved in the data center and research center.
2.4 Blinding Method: This research adopts an open design.
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
- •cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition
- •No distant metastasis, no direct 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) class 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
- •History of an iodine allergy
- •Patients who declined laparoscopic surgery
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 or death
次要结局
- Operation time(1 day)
- Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)(1 day)
- Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate)(1 day)
- Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate)(1 day)
- 3-year overall survival rate(3 years)
- Postoperative nutritional status(3 years)
- Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A(1 day)
- Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)(1 day)
- Postoperative recovery course(30 days)
- Intraoperative situation(30 days)
- Inflammatory and immune response(30 days)
- Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)(1 day)
- Total number of retrieved lymph nodes(1 day)
- Noncompliance rate of lymph node dissection(1 day)
- Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate)(1 day)
- Number of metastatic lymph nodes(1 day)
- Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B(1 day)
- Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate)(1 day)
- Metastasis rate of lymph nodes(1 day)
- 3-year recurrence pattern(3 years)
- Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate)(1 day)
- Morbidity and mortality rates(30 day)
- Postoperative quality of life (measured by EQ-5D)(preoperative, postoperative 1 month and postoperative 1 year)
研究者
Chang-Ming Huang, Prof.
Professor
Fujian Medical University Union Hospital