Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 1700

Inclusion Criteria

1. Men and women aged 19-70 who underwent endoscopic resection for early gastric cancer
2. Final pathological results after endoscopic resection met the absolute or expanded criteria according to the Japanese Gastric Cancer Treatment guideline 2014 (version 4)
3. Patients who had negative H. pylori status or those who eradicated H. pylori status
4. Willingness to sign an informed consent form

Exclusion Criteria

1. Pateints who received aspirin for the secondary prevention of cardiovascular diseases or cerebrovascular diseases
2. Regular aspirin uses (more than 3 times a week) with 2 months before screening visit
3. Patients who used anticoagulants or antiplatelet drugs for therapeutic purpose
4. Previous gastrectomy history
5. Current treatment for serious medical condition which could hinder participation (such as severe heart dysfunction, liver cirrhosis, renal failure, COPD or bronchial asthma, or uncontrolled infection)
6. High risk patients for bleeding complications (cerebral aneurysm, vascular malformation, esophageal or gastric varices, or hemophilia, etc)
7. Active peptic ulcer disease (patients who treated peptic ulcer completely could be enrolled)
8. Diagnosis and active treatment for other organ cancer (except carcinoma in situ, and non-melanoma skin cancer) within 5 years
9. Non-curative resection of early gastric cancer after endoscopic resection
10. Aspirin allergy or contraindication of aspirin use
11. Pregnant or lactating women
12. Alcoholism, drug abuse
13. Inadequte patients for study enrollment according to the evaluation of the study physician
14. Inability to provide an informed consent
15. Patients who took a 28-day run-in-period medication less than 80%

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of gastric cancer between the intervention and placebo groups

Secondary Outcome Measures

Name	Time	Method
All-cause mortality;The incidence of cardiovascular disease and cerebrovascular disease between the intervention and placebo groups;The incidence of other organ cancers between the intervention and placebo groups;The incidence of gastric dysplasia (adenoma) between the intervention and placebo groups;Complication related to the aspirin use;Improvement of atrophy and intestinal metaplasia