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

• Status: Recruiting
• Trial end date: 2028-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Collaborators: Asan Medical Center; Chilgok Kyungpook National University; Chonnam National University Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Hallym University Medical Center; Incheon St.Mary's Hospital/The Catholic University; Kosin University Gospel Hospital; Pusan National University Hospital; Seoul National University Hospital; SMG-SNU Boramae Medical Center
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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%