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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 主要终点
- Complete ablation rate 6 weeks after APC treatment.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients were blinded to the power settings used for APC, but they knew the PPI dose they received. The endoscopist performing APC ablation was blinded to participant allocation and APC power setting (the power was set up by an assistant who knew the group allocation and the power display remained covered during the entire procedure). The endoscopist and pathologist involved in efficacy assessment were blinded to participant allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: Argon Plasma Coagulation 90W power (Device)
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)
干预措施: Omeprazole 120 mg (Drug)
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)
干预措施: Argon Plasma Coagulation 90W power (Device)
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)
干预措施: Omeprazole 40 mg (Drug)
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)
干预措施: Argon Plasma Coagulation 60W power (Device)
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)
干预措施: Omeprazole 120 mg (Drug)
结局指标
主要结局
Complete ablation rate 6 weeks after APC treatment.
时间窗: 6 weeks
Complete ablation was defined as no endoscopic and histologic evidence of Barrett's mucosa, dysplasia, and buried metaplastic glands
次要结局
- Adverse event rate during APC treatment and within 6-week post-treatment period(6 weeks)
- Complete ablation rate two years after APC treatment(2 years)
- Complete ablation rate at the end of follow-up(Long term follow-up (>4 yars))