Patients who underwent endoscopic submucosal dissection (ESD) for early gastric cancer
Conditions
Interventions
Aspirin 81 mg once daily for up to 5 years
Nothing
Sponsors
MEGA trial Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Achieved absolute or expanded curative resection with ESD defined as per JGCA guidelines 2) Aged 20-80 years 3) Performance Status (ECOG) 0, 1, or 2 4) H. pylori infection was eradicated within 5 years or negative before enrollment 5) Will be followed over 5 years 6) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Allergy to aspirin treatment 2) Other gastric neoplasm including low grade adenoma remain 3) A history of H. pylori eradication therapy received more than 5 years ago 4) Lesions of Siewert Type II (<2 cm from the OGJ at the epicenter) 5) A history of gastric surgery 6) Severe co-morbidities and estimated life expectancy less than 3 years 7) Already on aspirin or other antithrombotic drugs prior to randomization 8) Using NSAIDs 9) Using Metformin 10) A history of peptic ulcers 11) A history of stroke 12) Receiving chemotherapy 13) Disorder of blood coagulation or platelet < 100,000/microliter 14) Pregnancy 15) Breast-feeding 16) Lack of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative incidence rate of metachronous gastric carcinoma at 5 years after ESD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events rate Histological evaluation of gastric mucosal atrophy and intestinal metaplasia Microbiota changes in stool and oral swab | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactSho Suzuki
Nihon University School of Medicine Division of Gastroenterology and Hepatology, Department of Medicine,
Outcome results
None listed