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临床试验/NCT03857737
NCT03857737尚未招募不适用

A Study Which Compares the Long Term and Short Term Outcomes Between Endoscopic Submucosal Dissection and Surgery in the Treatment of Early Gastric Cancer

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年3月1日最近更新:
适应症
干预措施

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shigang Ding

Attending, Chief of the Gastrointestinal Department of Peking University Third Hospital

Peking University Third Hospital

研究点 (1)

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