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

Peking University

Status: Not yet enrolling

Conditions: Early Gastric Cancer

Treatments: Procedure: Surgery; Procedure: endoscopic submucosal dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT03857737

PUTH020301ESD

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

ESD group

Experimental group

Description:

This group include patients who are going to undergo endoscopic submucosal dissection for early gastric cancer.

Treatment:

Procedure: endoscopic submucosal dissection

Surgery group

Active Comparator group

Description:

This group include patients who are going to undergo surgery for early gastric cancer.

Treatment:

Procedure: Surgery