Laparoscopic-assisted Total Gastrectomy Versus Open Total Gastrectomy With Spleen-preserving Splenic Hilum Lymph Nodes Dissection for Advanced Proximal Gastric Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Early complication rate
研究概览
简要总结
This study investigates the safety and feasibility of laparoscopic-assisted total gastrectomy with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy.
详细描述
For advanced proximal gastric cancer, total gastrectomy with D2 lymphadenectomy is the standard surgical therapy. Apparently, lymph nodes (LNs) dissection along the splenic artery (No.11) and the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines. Nevertheless, complete removal of the No. 10 and No. 11d LNs is technically challenging due to the tortuous splenic vessels and the high possibility of injury to the parenchyma of the spleen and pancreas. Recently, the application of minimally invasive surgery for advanced gastric cancer is gaining popularity. However, laparoscopic-assisted total gastrectomy (LATG) with standard D2 lymphadenectomy was still not widely performed, because pancreas- and spleen-preserving splenic hilum lymph node dissection were mainly challenging manipulations for laparoscopic surgeons. Herein, we aim to investigate the safety and feasibility of LATG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compares the early results of this procedure with open total gastrectomy (OTG).
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
- •Patient with advanced proximal gastric cancer （T2-T4a,N0-N3,M0）
- •Informed consent
- •Eastern Cooperative Oncology Group (ECOG): 0 ot 1
- •American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ
排除标准
- •Pregnancy or female in suckling period
- •Contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
- •Severe mental disease
- •Emergency operation due to complication (bleeding, perforation or obstruction) caused by primary tumor
- •Body mass index (BMI) > 30 kg/m2
结局指标
主要结局
Early complication rate
时间窗: 30 days
The early complication rate is defined as the event observed during operation and within 30 days after surgery.
次要结局
- Number of group No.10 lymph nodes harvested(7 days)
- Number of lymph nodes posterior to splenic vessel(7 days)
- Poster-operative recovery course(30 days)
- 3-year disease free survival rate(3 years)
- 5-year overall survival rate(5 years)
- Metastasis rate of lymph nodes posterior to splenic vessel(7 days)
- Operative time(Intraoperative)
- Time of splenic hilum lymph nodes dissection(Intraoperative)
- Operative blood loss(Intraoperative)
- Incision length(7 days)
- Number of total lymph nodes harvested(7 days)
研究者
Wei Wang
M.D., PhD.
Guangdong Provincial Hospital of Traditional Chinese Medicine