Laparoscopic Gastrectomy for Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- 3 year recurrence free survival
研究概览
简要总结
Although laparoscopic gastrectomy (LG) is widely used for the treatment of early gastric cancer, there have been few reports of the efficacy of LAG in the management of advanced gastric cancer(AGC). The aim of this study is to evaluate the surgical outcomes and oncologic safety of laparoscopic gastrectomy for AGC.
详细描述
Prospective phase II clinical trial to evaluate technical and oncological safety of LG for AGC
LG procedure for AGC:
D2 lymphadenectomy Total omentectomy for tumor with serosa exposure under laparoscopic exploration
Primary end point: 3 year disease free survival secondary end point: postoperative outcomes, morbidity and mortality, 3,5 and 7 year overall survival, Quality of life, recurrence pattern
Study duration: 7 years(enrollment: 4year, follow-up: 3year)
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-80
- •informed consent
- •no other malignancies
- •cT2N0-cT3N2 according to JGCA 2nd edition
- •ASA score<3
排除标准
- •distant metastasis(P1 or M1) under laparoscopic exploration
- •Conglomerated N2
- •early gastric cancer in permanent pathologic report
结局指标
主要结局
3 year recurrence free survival
时间窗: Postoperative 3 year
Evaluation of recurrence after regular 3 months follow-up using tumor marker, chest x-ray, endoscopy and computed tomograhy.
次要结局
未报告次要终点
研究者
Hyung-Ho Kim
Principal Investigator
Seoul National University Bundang Hospital