HybridAPC for the Treatment of Gastric Low Grade Intraepithelial Neoplasia (LGIN): a Prospective, Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Complete ablation of gastric low grade intraepithelial neoplasia
研究概览
简要总结
This cohort study aims to investigate the clinical efficacy and safety of Hybrid APC for treatment of gastric low grade intramucosal neoplasia.
详细描述
This cohort study aims to investigate the clinical efficacy and safety of Hybrid APC for treatment of gastric low grade intramucosal neoplasia. Successful ablation is defined as no evidence of local recurrence at 12 months after HybridAPC upon follow up endoscopy. This is defined as absence of LGIN, HGIN and cancer in biopsies obtained at all locations during followup endoscopy.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Low grade intraepithelial neoplasia of stomach with size≤20 mm
- •Endoscopic diagnosis suspected gastric LGIN with biopsy confirmed gastric LGIN
- •Endoscopic appearance according to Paris classification of Type 0-IIa, IIb or IIc
- •Patients with informed consent
排除标准
- •Patients who had previous endoscopic treatment (including APC, EMR, ESD) for gastric LGIN, HGIN or gastric carcinoma.
- •Endoscopic evidence of ulcer
- •Biopsy confirmed HGIN
- •Endoscopic diagnosis suspected HGIN while biopsy confirmed LGIN
- •informed consent not available
结局指标
主要结局
Complete ablation of gastric low grade intraepithelial neoplasia
时间窗: 12 months
Successful ablation is defined as no evidence of local recurrence at 12 months after HybridAPC upon follow up endoscopy. This is defined as absence of LGIN, HGIN and cancer in biopsies obtained at all locations during followup endoscopy.
次要结局
- Operative time(1 day)
- Intraoperative bleeding(1 day)
- Development of new neoplasia(12, 24 and 36 months)
- Number of HybridAPC procedures required for treatment(12 months)
- Pain after procedure(3 days)
- Progression of Low grade intraepithelial neoplasia(12, 24 and 36 months)
- Postoperative complications(7 days)
研究者
Philip Wai Yan CHIU
Professor
Chinese University of Hong Kong