Application of hybridAPC in the Treatment of Barrett: a Multicenter, Prospective Study
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- radical rate
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of the new technique of HybridAPC in the treatment of Barrett.
详细描述
After thermal ablation of Barrett's esophagus, stricture formation is reported in 5 to over 10% of patients. Submucosal fluid injection prior to ablation may lower the risk of stricture formation. The new technique of HybridAPC which combines submucosal injection with APC is considered to reduce the complication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age is from 18 to
- •Patients who were diagnosed with Barrett's esophagus.
- •Informed consent.
排除标准
- •Patient with severe cardiopulmonary dysfunction is unable to tolerated by endoscopy.
- •Severe bleeding tendency.
- •Poor compliance.
- •Patient is very ill and life expectancy is less than 2 years.
- •Esophageal varices or venous aneurysms, and no effective prevention or treatment for bleeding.
- •Severe esophageal stenosis.
- •Lesion is located in esophageal diverticulum or spread their diverticulum.
研究组 & 干预措施
HybridAPC
The patient with Barrett's esophagus is treatment by HybridAPC.
干预措施: HybridAPC (Device)
结局指标
主要结局
radical rate
时间窗: 3 months
Radical rate was defined as it that after 3 months of treatment, the primary lesion area returning to normal is reconfirmed by pathological diagnosis.
次要结局
- adverse event(1 year)
- operation time(1 day)
- recurrence(3 months)
研究者
Zhaoshen Li
Director of Gastroenterology Dept
Changhai Hospital