NCT03857737

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Early Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	endoscopic submucosal dissection	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.
PROCEDURE	Surgery	Surgery for EGC include Distal, proximal, or total gastrectomy, which will be performed according to the location and macroscopic tumor type by experienced surgeons.

Timeline

• Start date: 2019-03-01
• Primary completion: 2029-12-31
• Completion: 2029-12-31
• First posted: 2019-02-28
• Last updated: 2019-02-28

Locations

1 site across 1 country: China