A Study Which Compares the Long Term and Short Term Outcomes Between Endoscopic Submucosal Dissection and Surgery in the Treatment of Early Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 5-year OS
研究概览
简要总结
In this study, patients who are going to undergo endoscopic submucosal dissection (ESD) or surgery for early gastric cancer will be enrolled and divided into ESD group and Surgery group according to the procedure they go through. The patients will be followed up for at least 5 years after ESD or surgery. Esophagogastroduodenoscopy (EDG) and biopsy will be performed 3 months and then 6 months after ESD or surgery. Thereafter, EDG will be performed along with biopsy and abdominal computed tomography annually up to 5 years. Patients' data such as age, sex, clinical diagnosis, achievement of en-bloc resection, pathological outcomes, complications and survival condition will be prospectively collected. Statistical methods such as Student's t-test, the chi-square test, the Kaplan-Meier method and the log-rank test will be used to compare the short term and long term outcomes between the ESD group and the surgery group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed as early gastric cancer
- •Willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer
排除标准
- •Advanced stage gastric cancer
- •Not willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer
- •Not willing to participate in this study
研究组 & 干预措施
ESD group
This group include patients who are going to undergo endoscopic submucosal dissection for early gastric cancer.
干预措施: endoscopic submucosal dissection (Procedure)
Surgery group
This group include patients who are going to undergo surgery for early gastric cancer.
干预措施: Surgery (Procedure)
结局指标
主要结局
5-year OS
时间窗: From March 1 2019 to December 1 2024
5-year OS is the five year overall survival of each individual group. It will be estimated by Kaplan-Meier method, and statistical significance of differences between the two groups will be assessed using the log-rank test.
5-year DSS
时间窗: From March 1 2019 to December 1 2024
5-year DSS is the five year disease specific survival of each individual group. It will be estimated by Kaplan-Meier method, and statistical significance of differences between the two groups will be assessed using the log-rank test.
次要结局
- Complication(From March 1 2019 to December 1 2024)
研究者
Shigang Ding
Attending, Chief of the Gastrointestinal Department of Peking University Third Hospital
Peking University Third Hospital
