NL-OMON51866招募中不适用
Endoscopic mucosal Resection versus Endoscopic subMucosal dissection fOr removal of Visible lesions in Barrett*s Esophagus with early neoplasia: a randomized controlled trial - REMOVE RCT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
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 64（—）
入选标准
- •- Patients age: >= 18 years
- •- Willingness to undergo both EMR or ESD
- •- Ability to provide written, informed consent (approved by IRB) and understand
- •the responsibilities of trial participation
- •- BE with a single visible lesion with absence of signs of submucosal invasion
- •on endoscopy, after evaluation by the adjudication committee.
- •- Minimum diameter of the lesion >=15mm (in either direction)
排除标准
- •- Patients with visible lesions with suspicion of submucosal invasion bases on
- •assessment of the adjudication committee
- •- History of esophageal surgery other than fundoplication
- •- History of esophageal ablation therapy or endoscopic resection
- •- Multiple visible lesions in the BE segment at baseline
- •- Uncontrolled coagulopathy with INR >2.0, thrombocytopenia with platelet
- •counts < 50,000
- •- Subject has a known history of unresolved drug or alcohol dependency that
- •would limit ability to comprehend or follow instructions related to informed
- •consent, post-treatment in-structions, or follow-up guidelines
- •- Life expectancy <2 years
研究者
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