Effect of Low-dose Aspirin for Stomach Cancer Prevention After Endoscopic Resection of Gastric Neoplasm (EASTERN): a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,700
- 试验地点
- 10
- 主要终点
- The incidence of gastric cancer between the intervention and placebo groups
研究概览
简要总结
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.
详细描述
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 a 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 or high-grade dysplasia patients who underwent endoscopic resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 19-70 years who underwent endoscopic resection for high-grade adenoma or early gastric cancer (category 4 [non-invasive high grade neoplasm] or category 5 [invasive neoplasia] according to the Vienna classification of gastrointestinal epithelial neoplasia [Schlemper RJ, et al. Gut 2000;47:251-255.])
- •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
排除标准
- •Patients 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
- •Inadequate 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%
研究组 & 干预措施
Aspirin
Enteric coated aspirin
干预措施: Aspirin 100mg (Drug)
Placebo
Enteric coated aspirin placebo
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
The incidence of gastric cancer between the intervention and placebo groups
时间窗: Until last enrolled patients take 5-year trial medication
Histologically confirmed gastric cancer detected at follow-up endoscopy or registered at the Korean Cancer Registry
次要结局
- The incidence of gastric dysplasia (adenoma) between the intervention and placebo groups(Until last enrolled patients take 5-year trial medication)
- All-cause mortality(Until last enrolled patients take 5-year trial medication)
- The incidence of cardiovascular disease and cerebrovascular disease between the intervention and placebo groups(Until last enrolled patients take 5-year trial medication)
- Complication related to the aspirin use(Until last enrolled patients take 5-year trial medication)
- The incidence of other organ cancers between the intervention and placebo groups(Until last enrolled patients take 5-year trial medication)
- Improvement of atrophy and intestinal metaplasia(At the time of 5-year trial medication)
研究者
Il Ju Choi
Gastroenterologist
National Cancer Center, Korea