Argon Plasma Coagulation for Barrett’s Esophagus

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: February 10, 2015

Interventions

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

Arms, Groups and Cohorts

  • Experimental: APC 90W / PPI 120mg
    • treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)
  • Active Comparator: APC 90W / PPI 40mg
    • treatment with high-power argon plasma coagulation (90 Watt) followed by acid suppression with standard dose oral omeprazole (40 mg q.d)
  • Active Comparator: APC 60 W/ PPI 120mg
    • treatment with standard-power argon plasma coagulation (60 Watt) followed by acid suppression with high-dose oral omeprazole (40 mg t.i.d)

Clinical Trial Outcome Measures

Primary Measures

  • Complete ablation rate 6 weeks after APC treatment.
    • Time Frame: 6 weeks
    • Complete ablation was defined as no endoscopic and histologic evidence of Barrett’s mucosa, dysplasia, and buried metaplastic glands

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Maria Sklodowska-Curie National Research Institute of Oncology
  • Collaborator
    • Centre of Postgraduate Medical Education
  • Provider of Information About this Clinical Study
    • Sponsor

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