NL-OMON42316已完成不适用
Randomized controlled trial comparing the simplified and standard regimen for focal radiofrequency ablation - Simplified focal ablation RCT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients aged 18-85 years.
- •2. BE with biopsy proven LGD, HGD or EC confirmed after expert pathology review, with residual endoscopically visible Barrett*s mucosa, with or without prior ER and/or circumferential RFA.
- •3. Written informed consent.
排除标准
- •1. Significant esophageal stenosis prior to the first focal RFA treatment, preventing passage of a therapeutic endoscope OR any prior endoscopic dilatation for esophageal stenosis.
- •2. Presence of esophageal varices.
- •3. Anti-coagulant therapy (apart from aspirin or NSAID) that cannot be discontinued prior to ER or RFA, OR uncorrectable hemostatic disorders.
- •4. In case of prior ER: a specimen showing carcinoma with positive vertical resection margins, deep submucosal invasion (>T1sm1), poorly or undifferentiated cancer (G3 or G4), or lymphatic/vascular invasion.
- •5. In case of prior ER: invasive cancer in any of the biopsies obtained at high-resolution endoscopy after ER.
- •6. Patients unable to give informed consent.
- •7. No justification for further treatment due to (unrelated) comorbidity.
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