A randomised study comparing Endoscopic Full Thickness Plication (GERD-X) vs. Sham for esophageal abnormal acid exposure post Peroral endoscopic myotomy in patients with achalasia cardia
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 of abnormal acid exposure by 24 hr ph study
研究概览
简要总结
In patients who undergo POEM develop GERD who need to be managed with PPI. Of late trials have evaluated the efficacy of endoscopic plication technique for GERD and reported encouraging results. Endoscopic plication (GERD-X) is an alternative and less invasive procedure compared to laparoscopic fundoplication for the treatment of GERD. In endoscopic plication, transmural sutures are applied at the gastro-esophageal (GE) junction thereby reconstructing the gastric cardia and accentuating the valvular mechanism to prevent acid reflux. In this study we aim to evaluate the outcomes of GERD-X and compare it with Sham for esophageal abnormal acid exposure post Peroral endoscopic myotomy in patients with achalasia cardia in a randomized manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex aged 18-70 years and above
- •Aachalasia cardia patients minimum 3 months post POEM with abnormal 24hr pH metry, regardless of symptoms
- •Abnormal esophageal acid exposure defined as percentage time esophageal pH less than 4 of more than 4.2% on pH-metry during 24-h period while off PPI for atleast 1 week
- •Patients agreeing to informed consent.
排除标准
- •Failed POEM – elevated integrated relaxation pressure and lower esophageal sphincter pressure
- •Hiatus hernia hills 3 or more
- •Patients with significant renal or liver disease
- •Grade D esophagitis
- •Barrett’s esophagus
- •ASA physical status >II 7.
结局指标
主要结局
Improvement of abnormal acid exposure by 24 hr ph study
时间窗: 1 month
次要结局
- Improvement in GERD-Q(1 month and 3 months)