Metachronous gastric cancer prevention with aspirin:A multi-center randomized trial

Phase 2

• Conditions: Patients who underwent ESD for early gastric cancer; Early gastric cancer, metachronous Gastric cancer, cancer prevention

• Registration Number: JPRN-jRCTs031180437
• Lead Sponsor: Gotoda Takuji

Brief Summary

This study was discontinued.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-27
• Study Completion: 2020-12-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

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

1) Allergy to aspirin treatment
2) A history of H. pylori eradication therapy received more than 5 years ago
3) Lesions of Siewert Type II (<2 cm from the OGJ at the epicenter)
4) A history of gastric surgery
5) Severe co-morbidities and estimated life expectancy less than 3 years
6) Already on aspirin or other antithrombotic drugs prior to randomization
7) Using NSAIDs
8) Using Metformin
9) A history of peptic ulcers
10) A history of stroke
11) Receiving chemotherapy
12) Disorder of blood coagulation or platelet < 100,000/microliter
13) Pregnancy
14) Breast-feeding
15) Lack of informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified