Argon Plasma Coagulation for Barrett's Esophagus

Study Overview
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Brief Summary
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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.

Official Title
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Argon Plasma Coagulation for Barrett's Esophagus With Low Grade Dysplasia: A Randomized Trial With Long Term Follow-up Evaluating the Impact of Power Setting and Proton Pump Inhibitor Dose

Conditions
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Barretts Esophagus With Low Grade Dysplasia

Intervention / Treatment
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* Device: Argon Plasma Coagulation 90W power
* Device: Argon Plasma Coagulation 60W power
* Drug: Omeprazole 120 mg
* Drug: Omeprazole 40 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Investigator initiated, single-center, parallel-group RCT conducted in a tertiary referral center in Poland.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APC 90W / PPI 120mg<br>treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d) | Device: Argon Plasma Coagulation 90W power<br> <br> Drug: Omeprazole 120 mg<br> <br> |
| Active Comparator: APC 90W / PPI 40mg<br>treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with standard dose oral omeprazole (40 mg q.d) | Device: Argon Plasma Coagulation 90W power<br> <br> Drug: Omeprazole 40 mg<br> <br> |
| Active Comparator: APC 60 W/ PPI 120mg<br>treatment with standard-power argon plasma coagulation (60 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d) | Device: Argon Plasma Coagulation 60W power<br> <br> Drug: Omeprazole 120 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete ablation rate 6 weeks after APC treatment. | Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event rate during APC treatment and within 6-week post-treatment period |  | 6 weeks | 
| Complete ablation rate two years after APC treatment | Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands | 2 years | 
| Complete ablation rate at the end of follow-up | Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands | Long term follow-up (>4 yars) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barretts Esophagus, Dysplasia, Argon Plasma Coagulation, Endoscopic Treatment