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Clinical Trials in China / NCT03857737
Starting soon Not applicable

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

NCT03857737 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Third Hospital
Phase
Not applicable
Started
2019-03-01
Last updated
2019-02-28

Condition(s) studied

Early Gastric Cancer

Investigational drug(s) / intervention(s)

endoscopic submucosal dissectionSurgery

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
Max age
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Third Hospital Beijing Beijing Municipality

More Peking University Third Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03857737 on ClinicalTrials.gov ↗ ← All trials in China