NCT01882478已完成不适用
CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Response
研究概览
简要总结
The purpose of this study is to determine whether cryotherapy is effective in the treatment of persistent high grade dysplasia (HGD) or early esophageal adenocarcinoma (IMCA) in patients who have not responded to radiofrequency ablation (RFA).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age > 18 years old
- •Able to provide informed consent
- •Patients with unifocal or multifocal BE with HGD or IMCA who have failed at least 2 serial RFA therapy.
- •Patients who refused esophagectomy or deemed inoperable or whose BE dysplasia is not amenable to endoscopic mucosal resection (EMR) treatment alone due to: (1) extensive multifocal lesions (2) severe coagulopathy or any medical condition deemed high risk for EMR (3) patient refuses EMR
- •Patients with a nodular BE lesions may undergo clinically-indicated EMR and still be eligible for enrollment as long as they have BE-HGD lesion/s that are still candidate for ablative treatment
排除标准
- •Age younger than 18 years old
- •Life expectancy less than 12 months
- •Pregnancy
- •Presence of esophageal varices
- •Esophageal stricture precluding passage of an endoscope and suction tubing
- •Any procedure that has impeded normal gastric emptying or limited gastric volume distention, including but not limited to gastric bypass, stomach stapling, gastrojejunostomy or any disease state has significantly reduced the elasticity in the GI tract (e.g. Marfan's syndrome, Scleroderma or any Connective Tissue Disease)
- •Esophageal cancer (T2 and above)
结局指标
主要结局
Response
时间窗: 2 years
To assess efficacy of achieving elimination of dysplasia in patients with RFA-refractory BE with HGD or IMCA
次要结局
- Predictors of response(2 years)
研究者
Kenneth K. Wang
Kathy and Russ VanCleve Professor of Gastroenterology Reserach
Mayo Clinic
研究点 (1)
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