Clinical Efficacy and Safety Evaluation of Submucosal Injection of Indocyanine Green Tracer in 3D Fluorescent Laparoscopic Lymph Node Dissection for Gastric Cancer: a Prospective, a Multicenter, Randomized, Controlled Study Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 484
- 试验地点
- 1
- 主要终点
- 2-year disease free survival rate
研究概览
简要总结
Purpose of the study To evaluate whether the clinical efficacy of submucosal injection of indocyanine green tracer laparoscopic gastric cancer lymph node dissection is superior to that of laparoscopic gastric cancer lymph node dissection without indocyanine green tracer in 3D fluorescence laparoscopic mode in patients with gastric adenocarcinoma (cT1-4a, N-/+, M0). To observe the role of submucosal injection of ICG for tumor localization in fluorescence 3D fluorescence laparoscopic surgery and the application of lymph node dissection in laparoscopic radical surgery for gastric cancer.
Study design. Multicenter, randomized, open, parallel-controlled, superiority design. Subgroups Group A (experimental group): indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group Group B (control group): no indocyanine green tracer 3D laparoscopic gastric cancer lymph node dissection group.
Study population Patients who met all the inclusion criteria and did not fall into any of the exclusion criteria were eligible to enter this study.
Randomization Patients were first evaluated preoperatively to determine that they could receive laparoscopic radical gastric cancer treatment and receive endoscopic indocyanine green labeling. Once the enrolled cases were determined to meet the admission criteria after laparoscopic exploration, they could be enrolled in this study for randomization. The central dynamic, stratified zone randomization method was used in this study, and the control factors considered were age, tumor site, and preoperative stage. Given the number of seeds and the length of the zones, SAS 9.2 programming was applied to generate the treatment allocation corresponding to the running number 484, which was deposited in the data center. A person at the participating research center was responsible for sending the enrolled case information (age, tumor site, and preoperative stage) to the randomization implementation department at the data center by email, phone, or SMS, and the contact person at each respective research center confirmed that the patient met the enrollment criteria, contacted the contact person for the assigned case in this study, and determined the enrollment of the case by further analyzing the case information, and at the same time, notified the contact person at the research center where the case was located The contact person of the research center where the case is located will be notified at the same time. Competitive enrollment was used in this study.
Blinding.
详细描述
Case enrollment period: complete enrollment of the required cases within 2 years.
Follow-up period: The 1st case enrollment is the starting point for follow-up, and the last case enrollment to the time of return of the postoperative pathology report (usually 2 weeks postoperatively) is the endpoint of follow-up for secondary study purposes except for the 2-year recurrence type. 2 years after the last 1 case enrollment is the follow-up endpoint for the primary study purpose.
Estimated time: 2024.5-2026.4 (completion of enrollment) - 2028.4 (completion of follow-up) Standardization of Surgical Procedures. Commonly followed principles of handling in both groups Anesthesia All surgeries were performed under general anesthesia with tracheal intubation; the use of epidural-assisted anesthesia depended on the anesthesiologist and was not prescribed in this study.
Obtaining cytologic specimens for abdominal lavage After entering the abdominal cavity, firstly, the cytology specimen of abdominal lavage was retained for postoperative examination (Specific method: ascites was taken directly when ascites was found to be present. If there is no ascites, 100 ml of saline is slowly injected into the abdominal cavity, and the washings are collected and sampled in the Douglas fossa for examination.) Intraoperative exploration After obtaining cytologic specimens from abdominal lavage, the abdominal cavity is explored to check for metastases to the liver, peritoneum, mesentery, and pelvis, and invasion of the gastric plasma membrane.
Provisions for lymph node dissection Gastric cancer D2 lymph node dissection is performed according to the Japanese Guidelines for the Treatment of Gastric Cancer (5th ed.) Lymph node dissection is performed in patients in group A. After lymph node dissection, the NIR mode is used to check for the presence of missing lymph nodes, and if there are any, remedial dissection is performed.
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 (Participant)
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: 18-75 years old Gastric adenocarcinoma diagnosed histopathologically by endoscopic biopsy of the primary gastric lesion (pap, tub, muc, sig, por) The preoperative clinical stage was cT1-4a, N-/+, M0, according to the AJCC-8th TNM tumor stage.
- •Preoperative examination did not show distant metastasis, and the tumor did not directly invade the pancreas, spleen and other adjacent organs.
- •Preoperative ECOG physical status score 0/1 Preoperative ASA score I-III. Patient informed consent
排除标准
- •Pregnant or nursing women Serious mental illness History of upper abdominal surgery (except history of laparoscopic cholecystectomy) History of gastric surgery (including ESD/EMR for gastric cancer) Preoperative imaging suggestive of regional fusion of enlarged lymph nodes (maximum diameter ≥3cm) History of other malignant diseases within 5 years. Neoadjuvant therapy has been implemented History of unstable angina or myocardial infarction within 6 months History of cerebral infarction or cerebral hemorrhage within 6 months History of continuous systemic corticosteroid therapy within 1 month Require concomitant surgical treatment for other diseases. Gastric cancer complications (bleeding, perforation, obstruction) requiring emergency surgery.
- •Pulmonary function test FEV1 <50% of the expected value Diffusely invasive gastric cancer Preoperatively confirmed tumor invading the dentate line or duodenum Previous history of iodine allergy Refusal of laparoscopic surgery
结局指标
主要结局
2-year disease free survival rate
时间窗: 12 weeks
Observation of the rate of disease-free survival of patients two years after surgery
次要结局
未报告次要终点
研究者
Wenbin Yu
Professor， and Chief of Gastrointestinal Surgery Department
Qilu Hospital of Shandong University