Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection:a New Therapy for Early Gastric Cancer
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
The purpose of this study is to determine whether Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection for early gastric cancer can improve Disease-free survival ？
详细描述
Patients with early stage of gastric cancer(T1a/T1bN0M0,NCCN2014.V1) will depart into two group randomized double-blind, then experimental group accept Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection ,and control group accept Endoscopic Submucosal Dissection only.The follow-up time is from operation to recrudescence.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cT1a：ulcer（+）and lesion diameter>3cm and differentiated type. Any ulcer and lesion diameter d>2cm and poorly differentiated type.
- •cT1b: Submucosal injection (+)
排除标准
- •metastasis
- •recrudescence
研究组 & 干预措施
ESD and LRLD
The experimental group accept Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection.
干预措施: ESD AND LRLD (Procedure)
Endoscopic Submucosal Dissection (ESD)
The group accept Endoscopic Submucosal Dissection only.
结局指标
主要结局
DFS
时间窗: Five years
Follow-up Disease-free Survival
次要结局
未报告次要终点
研究者
Hua Meng
Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection for early gastric cancer
Beijing Friendship Hospital