Aspirin in Preventing Disease Recurrence in Patients With Barrett Esophagus After Successful Elimination by Radiofrequency Ablation

Summary

This randomized phase II trial studies the safety of and how well aspirin works in preventing Barrett's esophagus from returning after it has been successfully eliminated by radiofrequency ablation. Studying samples of tissue from patients with Barrett's esophagus for the levels of a specific protein that is linked to developing Barrett's esophagus may help doctors learn whether aspirin can prevent it from returning after it has been successfully treated.

Timeline

Start

2016-01-15

Primary completion

2019-06-18

Completion

2027-03-30

Outcome

Missed primary endpoint

registry analysis (superiority test); Arm A (Aspirin) vs Arm B (Placebo); p = 0.343; t-test, 2 sided NCT02521285 ↗

registry analysis (superiority test); Arm A (Aspirin) vs Arm B (Placebo); p = 0.878; t-test, 2 sided NCT02521285 ↗

registry analysis (superiority test); Arm A (Aspirin) vs Arm B (Placebo); p = 0.05; t-test, 2 sided NCT02521285 ↗

registry analysis (superiority test); Arm A (Aspirin) vs Arm B (Placebo); p = 0.53; t-test, 2 sided NCT02521285 ↗

registry analysis (superiority test); Arm A (Aspirin) vs Arm B (Placebo); p = 0.234; t-test, 2 sided NCT02521285 ↗

registry analysis (superiority test); Arm A (Aspirin) vs Arm B (Placebo); p = 0.645; t-test, 2 sided NCT02521285 ↗

Publications

• Bresalier RS. Chemoprevention of Barrett's Esophagus and Esophageal Adenocarcinoma. Dig Dis Sci. 2018 Aug;63(8):2155-2162. doi: 10.1007/s10620-018-5149-6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aspirin	Small molecule	325 mg	Oral

Indications