Endoscopic Radiofrequency Ablation for Gastric Metaplasia and Dysplasia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Histological clearance of dysplasia/metaplasia
研究概览
简要总结
Gastric intestinal metaplasia (IM) and dysplasia, also referred to as intra-epithelial neoplasia, are well recognized precursors of gastric cancer. Apart from endoscopic surveillance, there is no other intervention which predictably eradicates pre-cancerous gastric lesions.
Endoscopic radiofrequency ablative (RFA) therapy has been recently shown to be highly effective in eradicating both IM and dysplasia in patients with Barrett's esophagus. However, the potential role of RFA to remove gastric IM and dysplasia remains unknown. In this study, we determine the feasibility of using endoscopic RFA in treating early gastric neoplasia (metaplasia and dysplasia). Patients with gastric metaplasia and/or dysplasia will be treated with endoscopic RFA. The safety and effects of RFA will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of gastric IM or dysplasia.
- •The lesion is no larger than 5 cm in diameter.
- •Age ≥ 18 years.
- •No previous endoscopic mucosal resection or submucosal dissection.
- •No active H. pylori infection.
- •Subject is able to tolerate endoscopy and sedation.
- •Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form.
排除标准
- •Gastric cancer (intra-mucosal cancer or worse).
- •Prior gastric irradiation or surgery.
- •Anti-platelet or anti-thrombotic medication use that cannot be stopped for 7 days before and after RFA.
- •Gastric ulcers, fistulae and varices.
- •History of alcohol and/or controlled substance dependency.
结局指标
主要结局
Histological clearance of dysplasia/metaplasia
时间窗: 6 month
次要结局
- Number of Participants with Adverse Events(up to 6 month)
研究者
LEUNG Wai Keung
Clinical Professor
The University of Hong Kong