Laparoscopic 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
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of group Splenic Hilum (No.10) lymph nodes harvested
研究概览
简要总结
Splenic hilum remains challenging during total gastrectomy with D2 lymphadenectomy.The application of minimally invasive surgery for advanced gastric cancer is gaining popularity. The investigators aim to compare the safety and feasibility of LTG and OTG for advanced proximal gastric cancer.
详细描述
Total gastrectomy with D2 lymphadenectomy remains the standard surgical therapy for patients with advanced proximal gastric cancer. Although lymph nodes dissection along with the splenic hilum (No.10) is recommended by the Japanese Gastric Cancer Treatment Guidelines, however, complete removal of the No. 10 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 total gastrectomy (LTG) 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. Therefore,the investigators aim to investigate the safety and feasibility of LTG with spleen-preserving splenic hilum lymph node dissection for proximal advanced gastric cancer and compare 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
- •Primary proximal gastric adenocarcinoma confirmed pathologically by endoscopic biopsy;
- •cT2-4aN0-3M0 at preoperative evaluation according to American Joint Committee On Cancer (AJCC) Cancer Staging Manual, 7th Edition.
- •Eastern Cooperative Oncology Group (ECOG): 0 or 1;
- •American Society of Anesthesiologists （ASA） score: Ⅰto Ⅲ;
- •Written informed consent.
排除标准
- •Pregnant or breast-feeding women;
- •Severe mental disorder;
- •Previous upper abdominal surgery (except laparoscopic cholecystectomy);
- •Previous gastrectomy, endoscopic mucosal resection, or endoscopic submucosal dissection;
- •Enlarged or bulky regional lymph node diameter larger than 3 cm based on preoperative imaging;
- •Other malignant disease within the past 5 years;
- •Previous neoadjuvant chemotherapy or radiotherapy;
- •Contraindication to general anesthesia (severe cardiac and/or pulmonary disease);
- •Emergency surgery due to a complication (bleeding, obstruction, or perforation) caused by gastric cancer.
研究组 & 干预措施
Laparoscopic total gastrectomy
Participants including in the laparoscopic total gastrectomy (LTG) group will undergo LTG with spleen-preserving splenic hilum lymph nodes dissection.
干预措施: Laparoscopic total gastrectomy (Procedure)
Open total gastrectomy
Participants who are included in the open total gastrectomy (OTG) group will OTG with spleen-preserving splenic hilum lymph nodes dissection.
干预措施: Open total gastrectomy (Procedure)
结局指标
主要结局
Number of group Splenic Hilum (No.10) lymph nodes harvested
时间窗: 7 days
次要结局
- Post-operative recovery course(30 days)
- 3-year overall survival rate(3 years)
- Operative blood loss(Intraoperative)
- Time of splenic hilum lymph nodes dissection(Intraoperative)
- Operative time(Intraoperative)
- 3-year disease free survival rate(3 years)
- Quality of life(1 year)
- Early complication rate(30 days)
- Number of total lymph nodes harvested(7 days)
研究者
Lin Chen
Director
Chinese PLA General Hospital