Argon Plasma Coagulation for Barrett's Esophagus

Maria Sklodowska-Curie National Research Institute of Oncology

Status: Completed

Conditions: Barretts Esophagus With Low Grade Dysplasia

Treatments: Device: Argon Plasma Coagulation 60W power; Device: Argon Plasma Coagulation 90W power; Drug: Omeprazole 120 mg; Drug: Omeprazole 40 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04154748

0102

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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71 participants in 3 patient groups

APC 90W / PPI 120mg

Experimental group

Description:

treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)

Treatment:

Device: Argon Plasma Coagulation 90W power

Drug: Omeprazole 120 mg

APC 90W / PPI 40mg

Active Comparator group

Description:

treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with standard dose oral omeprazole (40 mg q.d)

Treatment:

Device: Argon Plasma Coagulation 90W power

Drug: Omeprazole 40 mg

APC 60 W/ PPI 120mg

Active Comparator group

Description:

treatment with standard-power argon plasma coagulation (60 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)

Treatment:

Device: Argon Plasma Coagulation 60W power

Drug: Omeprazole 120 mg