Study on Short and Long-term Outcome of Laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection for Advanced Middle or Upper Third Gastric Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- the incidence of postoperative complications within 30 days
研究概览
简要总结
The purpose of this study is to explore the safety and feasibility of laparoscopic spleen-preserving No. 10 lymph node dissection for patients with advanced middle or upper third gastric cancer.
详细描述
Radical resection is the primary treatment for patients with advanced middle or upper third gastric cancer. And D2 lymphadenectomy, including No. 10 lymph node dissection, should be performed according to the Japanese treatment guidelines for gastric cancer. Because of the complexity of the anatomy around the spleen, spleen-preserving No. 10 lymph node dissection is difficult. Although Professor Huang from Fujian Medical University Union Hospital has proposed the "Huang's three-step maneuver" to dissect No. 10 lymph node with preserved spleen laparoscopically, such method is far from popularized, especially in North China. In addition, the safety, feasibility and oncological efficacy of this method was not confirmed in such area, either.
In this study, a prospective, single center, single-arm, non-inferiority clinical trial will be conducted to evaluate the short and long-term outcome of the laparoscopic spleen-preserving No. 10 lymph node dissection for patients with locally advanced middle or upper third gastric cancer in Beijing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age older than 18 years (including 18 years old);
- •The primary lesion is located in the upper or middle third of the stomach, including Siewert II type and Siewert III type adenocarcinoma of the esophagogastric junction;
- •Pathologically confirmed primary gastric adenocarcinoma by endoscopic biopsy (including papillary, tubular, mucinous, signet ring cell and poorly differentiated adenocarcinoma);
- •Preoperative cancer stage cT2-4aN0-3M0 (according to AJCC-7th TNM staging);
- •The Eastern Cooperative Oncology Group performance status of 0 or 1;
- •The American Society of Anesthesiology classes of I, II or III;
- •Signed Informed consent.
排除标准
- •Pregnant or lactating women;
- •Suffering from severe mental disorder;
- •Previous gastrectomy, including endoscopic submucosal dissection and endoscopic mucosal resection;
- •Integrated or enlarged lymph node with maximum diameter larger than 3 cm according to preoperative imaging, including significantly enlarged or bulky No. 10 lymph nodes;
- •Siewert I type adenocarcinoma of the esophagogastric junction;
- •Other malignant diseases (within 5 years);
- •Other illnesses needed operation concurrently;
- •Complications (bleeding, perforation or obstruction) required emergency surgery due to primary gastric malignancy;
- •Pulmonary function tests FEV1 less than 50% of predicted value;
- •Patient suffered from bleeding tendency disease such as hemophilia or took anti-coagulant medication due to deep vein thrombosis.
- •Patients with obvious tumor infiltration in the spleen and splenic vessels which require splenectomy.
结局指标
主要结局
the incidence of postoperative complications within 30 days
时间窗: 30 days
次要结局
- 3-year disease free survival(36 months)
研究者
Xiangqian Su
Chief of GI surgery IV
Peking University Cancer Hospital & Institute