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

NCT03857737 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-02-28

No results posted yet for this 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.

Conditions

  • Early Gastric Cancer

Interventions

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.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03857737 on ClinicalTrials.gov