Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients
Aspirin Use for Gastric Cancer Prevention in the Early Gastric Cancer Patients
This study aimed to investigate the effect of low-dose (100 mg) asprin on the prevention of
 gastric cancer in the early gastric cancer patients with negative H. pylori status who
 underwent endoscopic submucosal dissection.
Aspirin has been widely used as an anti-platelet drug for the primary or secondary prevention
 of cardiovascular events, including ischemic heart disease and stroke. In 2016, the U.S.
 Preventive Services Task Force recommended initiating low-dose aspirin use for the primary
 prevention of cardiovascular diseases and colorectal cancer in adult aged 50 to 59 years who
 have a 10% or greater 10-year cardiovascular disease risk, are not at increased risk of
 bleeding, have a life expectancy of at least 10 years, and are willing to take low-dose
 aspirin daily for at least 10 years. In addition, a meta-analysis reported that long-term
 aspirin use was associated with reduced the risk of gastrointestinal cancers including
 colorectal cancer, esophageal cancer, and gastric cancer.However, most studies that reported
 the cancer prevention effect of long-term aspirin use were conducted as the secondary
 analysis or subgroup analysis of primary studies investigating the aspirin use for
 cardiovascular disease prevention. Thus, there is a limitation that appropriate sample sizes
 and follow-up periods for the cancer prevention effect of aspirin were not considered. In
 2018, we reported that H. pylori treatment reduced the development of metachronous gastric
 cancer after endoscopic resection in early gastric cancer patients. However, metachronous
 gastric cancer could develop after successful H. pylori eradication with an annual incidence
 of 1%-3%. Therefore, we designed a multi-center, double-blind, randomized, placebo-controlled
 trial to evaluate whether long-term low-dose (100 mg) aspirin uses prevents gastric cancer in
 early gastric cancer patients without H. pylori infection.
Inclusion Criteria:

 -  Men and women aged 19-70 who underwent endoscopic resection for early gastric cancer

 -  Final pathological results after endoscopic resection met the absolute or expanded
 criteria according to the Japanese Gastric Cancer Treatment guideline 2014 (version 4)

 -  Patients who had negative H. pylori status or those who eradicated H. pylori status

 -  Willingness to sign an informed consent form

 Exclusion Criteria:

 -  Pateints who received aspirin for the secondary prevention of cardiovascular diseases
 or cerebrovascular diseases

 -  Regular aspirin uses (more than 3 times a week) with 2 months before screening visit

 -  Patients who used anticoagulants or antiplatelet drugs for therapeutic purpose

 -  Previous gastrectomy history

 -  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)

 -  High risk patients for bleeding complications (cerebral aneurysm, vascular
 malformation, esophageal or gastric varices, or hemophilia, etc)

 -  Active peptic ulcer disease (patients who treated peptic ulcer completely could be
 enrolled)

 -  Diagnosis and active treatment for other organ cancer (except carcinoma in situ, and
 non-melanoma skin cancer) within 5 years

 -  Non-curative resection of early gastric cancer after endoscopic resection

 -  Aspirin allergy or contraindication of aspirin use

 -  Pregnant or lactating women

 -  Alcoholism, drug abuse

 -  Inadequte patients for study enrollment according to the evaluation of the study
 physician

 -  Inability to provide an informed consent

 -  Patients who took a 28-day run-in-period medication less than 80%