Safety and Efficacy of Single or Reduced Ports Laparoscopic Gastrectomy for Advanced Gastric Cancer (SPACE-01) Phase II Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- number of retrieved lymph nodes
研究概览
简要总结
The aim of this study is to verify the safety and efficacy of single or reduced ports laparoscopic gastrectomy for advanced gastric cancer.
详细描述
Since two cases of single-incision laparoscopic gastrectomy in early gastric cancer were reported in 2011, the safety and efficacy of single-incision laparoscopic gastrectomy in early gastric cancer have been reported several times.
Recently, the feasibility of laparoscopic single-incision gastrectomy in some advanced gastric cancer has already been reported.
The total number of retrieved lymph nodes during gastric cancer surgery is one of the most important indicators for securing oncological safety and predicting the therapeutic effect in gastric cancer surgery.
Therefore, in order to prospectively evaluate the efficacy of single-incision or reduced-port laparoscopic gastrectomy for advanced gastric cancer as an oncological operation, the purpose of this study is to evaluate the number of resected lymph nodes after D2 lymph node dissection in single-incision or reduced-port laparoscopic gastrectomy for advanced gastric cancer.
All surgeries are performed as single-incision laparoscopic surgery using a 3-4 cm umbilical incision, and D2 lymph node dissection is performed according to the Japanese gastric cancer treatment guidelines 2018 by the Japanese Gastric Cancer Association.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have confirmed that participants have advanced gastric cancer at clinical stage T2 or higher and who can undergo distal gastrectomy for primary gastric cancer who have consented to single-port and reduced-port laparoscopic gastric cancer surgery
- •Patients diagnosed with locally advanced gastric cancer in which no enlarged lymph nodes were observed in the preoperative examination, or lymph node metastases confined to the left gastric artery or perigastric area were suspected.
- •Those who have not been treated for systemic inflammatory disease before surgery
排除标准
- •Those who have previously had gastrectomy.
- •Those who have a laparotomy except for appendectomy, cholecystectomy or cesarean section.
- •Patients with clinical (preoperative or intraoperative) stage T4b accompanied by infiltration of surrounding organs
- •Those with bulky lymph nodes (single nodules over 3 cm or multiple nodules over 1.5 cm)
- •Patients with confirmed distant metastasis (M1)
- •Severe liver cirrhosis
- •Patients who is judged by the investigator to be inappropriate for this study
- •Patients who are taking antithrombotic drugs, including antiplatelet drugs and anticoagulants, and cannot safely stop before surgery
研究组 & 干预措施
Single port or reduced ports
Single port or reduced ports laparoscopic distal gastrectomy and D2 lymph node dissection
干预措施: Single port or reduced ports laparoscopic distal gastrectomy and D2 lymph node dissection (Procedure)
结局指标
主要结局
number of retrieved lymph nodes
时间窗: during operation
number of retrieved lymph nodes during operation
次要结局
- postoperative complications(3 year)
- Quality of life of the participants(before surgery (within 1 month before the day of surgery), within 1 week after surgery, within 1 month after surgery, within 3 months after surgery, within 6 months after surgery, and within 12 months after surgery)
- 3 year relapse-free survival(3 year)
研究者
Yun-Suhk Suh
Professor
Seoul National University Bundang Hospital