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

Not Applicable

Not yet recruiting

• Conditions: Early Gastric Cancer
• Interventions: Procedure: endoscopic submucosal dissection; Procedure: Surgery

• Registration Number: NCT03857737
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-02-27
• Last Update Submitted: 2019-02-27
• Study First Posted: 2019-02-28
• Last Update Posted: 2019-02-28
• Study Start: 2019-03-01
• Primary Completion: 2029-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Clinically diagnosed as early gastric cancer
• Willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESD group	endoscopic submucosal dissection	This group include patients who are going to undergo endoscopic submucosal dissection for early gastric cancer.
Surgery group	Surgery	This group include patients who are going to undergo surgery for early gastric cancer.

Primary Outcome Measures

Name	Time	Method
5-year OS	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	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 Outcome Measures

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

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China