Overview

Argon Plasma Coagulation for Barrett's Esophagus

Status:
Completed
Trial end date:
2019-07-05
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Maria Sklodowska-Curie Institute - Oncology Center
Collaborator:
Centre of Postgraduate Medical Education
Treatments:
Omeprazole
Criteria
Inclusion Criteria:

- consecutive adult patients with low-grade dysplasia in flat Barrett's mucosa referred
for endoscopic treatment,

- signed an informed consent to participate in the study.

Exclusion Criteria:

- high-grade dysplasia or adenocarcinoma,

- visible lesions (nodules, ulcerations) in Barrett's mucosa,

- serious comorbidities and short life expectancy,

- coagulopathy,

- pregnancy or lactation,

- psychiatric disorders.