Endoscopic Submucosal Dissection Versus Surgery in the Treatment of Early Gastric Cancer

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.

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

Conditions
-----------------
Early Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: endoscopic submucosal dissection
* Procedure: Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESD group<br>This group include patients who are going to undergo endoscopic submucosal dissection for early gastric cancer. | Procedure: endoscopic submucosal dissection<br>* Endoscopic submucosal dissection is an endoscopic procedure which can achieve en bloc resection of GI tumor. ESD is characterized by three steps: injecting fluid into the submucosa to elevate the lesion from the muscle layer, circumferential cutting of the surrounding mucosa of the lesion, and subsequent dissection of the connective tissue of the submucosa beneath the lesion. The ESD procedure will be carried out by experienced endoscopists.<br>|
| Active Comparator: Surgery group<br>This group include patients who are going to undergo surgery for early gastric cancer. | Procedure: Surgery<br>* Surgery for EGC include Distal, proximal, or total gastrectomy, which will be performed according to the location and macroscopic tumor type by experienced surgeons.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year OS | 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. | From March 1 2019 to December 1 2024 | 
| 5-year DSS | 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. | From March 1 2019 to December 1 2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication | Complications were classified according to the Clavien-Dindo classification and the frequency of the complications will be compared between the two groups. | From March 1 2019 to December 1 2024 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early gastric cancer, endoscopic submucosal dissection, surgery