ACTRN12617000402347招募中未知
Endoscopic ablation of dysplastic Barrett’s oesophagus
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Barrett's oesophagus with low grade dysplasia, high grade dysplasia or T1a adenocarcinoma
排除标准
- •a)C value greater than 6 cm using the Prague criteria
- •b)Prior ER for adenocarcinoma with histological diagnosis of greater than or equal to T1b;
- •c)Presence of endoscopically visible abnormalities at the time of initial APC treatment (additional endoscopic resection is allowed);
- •d)Presence of cancer in random biopsies obtained at the mapping endoscopy, 8-12 weeks before initial HAPC treatment without endoscopic resection of cancer lesion for staging;
- •e)Pregnancy
- •f)Patients in whom complete eradication is not considered a relevant treatment goal or in whom additional treatment is contraindicated;
- •g)Patients with incomplete healing post-endoscopic resection despite adequate PPI-medication;
- •h)Prior ablative therapy in the oesophagus;
- •i)Significant oesophageal stenosis prior to initial HAPC treatment defined as a stenosis that cannot be passed by a therapeutic endoscope or a stenosis that has been dilated endoscopically before.
- •j)Presence of esophageal varices
- •k)Anticoagulant therapy (apart from aspirin or NSAIDS) that cannot be discontinued prior to HAPC or incorrectable hemostatic disorders
- •l)Life expectancy less than 2 years
研究者
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