Phase II Clinical Study on the Safety and Efficacy of Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in Gastro Esophageal Reflux symptoms
研究概览
简要总结
This is a phase II clinical study to investigate the safety and efficacy of endoscopic antireflux mucosectomy (ARMS) for treatment of GERD.
详细描述
The objective of the study is to establish the clinical efficacy and safety of ARMS for treatment of GERD.
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 with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months
- •Hill's grade II and III of the gastroesophageal junction
- •One of the following abnormalities in the objective assessment 3.
- •Excessive acid exposure at the distal esophagus evidenced by 24 hour pH tests using % total time pH < 4 and / or DeMeester score 3.
- •Endoscopic evidence of LA classes A,B,C or D esophagitis 3.
- •Defective LES assessed by HRM with resting pressure of < 6mmHg or total length of less than 4cm or abdominal length of less than 2cm
排除标准
- •Age > 70 yrs of < 18 yrs
- •Any type of Hiatus hernia
- •Patients with underlying malignancy
- •ASA above grade III
研究组 & 干预措施
Antireflux Mucosectomy
Antireflux mucosectomy targeted at resection of gastric cardia muocsa to induce fibrosis and improve on the flap value over the gastroesophageal junction
干预措施: Antireflux Mucosectomy (Procedure)
结局指标
主要结局
Improvement in Gastro Esophageal Reflux symptoms
时间窗: 3 months
GERD symptoms evidence by the improvement in the Gastroesophageal Reflux Quality of Life (QoL) of ≥50% compared to the baseline off Proton Pump Inhibitors (PPI) value 3 months after the procedure
次要结局
- 24 hour pH study post ARMS(3 and 12 months)
- High resolution Manometry(3 and 12 months)
- Technical Success(1 day)
- Gastroesophageal junction classified by Hill's classification(3 and 12 months)
研究者
Philip Wai Yan CHIU
Professor
Chinese University of Hong Kong