A Study Which Compares the Long Term and Short Term Outcomes Between Endoscopic Submucosal Dissection and Surgery in the Treatment of Early Gastric Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- 5-year OS
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinically diagnosed as early gastric cancer
- •Willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer
Exclusion Criteria
- •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
Arms & Interventions
ESD group
This group include patients who are going to undergo endoscopic submucosal dissection for early gastric cancer.
Intervention: endoscopic submucosal dissection (Procedure)
Surgery group
This group include patients who are going to undergo surgery for early gastric cancer.
Intervention: Surgery (Procedure)
Outcomes
Primary Outcomes
5-year OS
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Complication(From March 1 2019 to December 1 2024)
Investigators
Shigang Ding
Attending, Chief of the Gastrointestinal Department of Peking University Third Hospital
Peking University Third Hospital