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NCT04154748

Argon Plasma Coagulation for Barrett's Esophagus

Completed NA Last updated 19 November 2019
What this trial tests

NA trial testing Argon Plasma Coagulation 90W power in Barretts Esophagus With Low Grade Dysplasia in 71 participants. Completed in 5 July 2019.

Timeline
4 June 2002
Primary endpoint
10 February 2015
5 July 2019

Quick facts

Lead sponsorMaria Sklodowska-Curie National Research Institute of Oncology
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment71
Start date4 June 2002
Primary completion10 February 2015
Estimated completion5 July 2019

Drugs / interventions tested

Conditions studied

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Who can join

18 and older, any sex, with Barretts Esophagus With Low Grade Dysplasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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