drugset / Trial / NCT04154748

Argon Plasma Coagulation for Barrett's Esophagus

NCT04154748

RandomizedParallel-groupDouble-blindTreatment

Summary

Background and study aims. To evaluate the impact of power setting and proton pump inhibitor (PPI) dose on the efficacy and safety of argon plasma coagulation (APC) of Barrett's esophagus (BE) with low-grade dysplasia (LGD). Patients and methods. Investigator initiated, single-center, parallel-group randomized controlled trial (RCT) conducted in a tertiary referral center in Poland. Consecutive patients with BE and LGD were randomly assigned to APC with power set at 90 Watt (90W) or 60 Watt (60W) followed by 120 mg or 40 mg omeprazole for six weeks. The primary outcome of the study was the rate of complete (endoscopic and histologic) ablation of BE at six weeks. Secondary outcomes included safety and long-term efficacy (at two years and at the end of a long-term follow-up of over 4 years.

Timeline

Start
2002-06-04
Primary completion
2015-02-10
Completion
2019-07-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Omeprazole Other / unclassified 40 mg Oral
Subject Omeprazole Other / unclassified 120 mg Oral

Indications