NOVEL HIGH-RESOLUTION MANOMETRY SCORE FOR THE DIAGNOSIS OF GASTRO-ESOPHAGEAL REFLUX DISEASE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- HRM score
研究概览
简要总结
The goal of this prospective study is to validate a high resolution manometry score to predict pathologic GERD in patients with reflux symptoms. The main question it aims to answer is:
Is it possible to predict GERD on high resolution manometry? Participants will be asked to undergo high resolution manometry and pH-study
详细描述
According to recent guidelines, high resolution manometry (HRM) has an ancillary role in the diagnosis of gastro-esophageal reflux disease (GERD). A recent multicenter study demonstrated the effectiveness of the straight leg raise (SLR) maneuver in predicting GERD, thus increasing the diagnostic value of HRM in patients with suspected pathological reflux. HRM parameters associated with GERD include esophageal body hypomotility such as ineffective esophageal motility (IEM), and esophagogastric junction (EGJ) metrics, particularly the EGJ contractile integral (EGJ-CI) that takes into consideration the presence or absence of a hiatal hernia (HH), and a hypotensive lower esophageal sphincter (LES). The combination of these four parameters might help to predict or exclude true GERD in patients undergoing HRM with the suspicion of GERD.
In this multicenter international prospective study, we aimed to build a score to predict pathological esophageal acid exposure time (AET>6%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HRM and wireless pH-study or catheter pH-impedance study performed for persistent GERD symptoms off proton-pump inhibitor (PPI) within two weeks of each other,
- •SLR maneuver performed at the end of HRM
排除标准
- •Body mass index (BMI) >35 Kg/m2
- •prior esophageal surgery
- •paraesophageal hiatal hernia
- •eosinophilic esophagitis
- •scleroderma
- •esophageal achalasia
结局指标
主要结局
HRM score
时间窗: From date of inclusion in the study until the diagnosis of GERD, up to 2 months
HRM score is based on EJG type, ineffective esophageal motility, straight leg raise maneuver and EGJ contractile integral
次要结局
未报告次要终点
研究者
Stefano Siboni
Medical Doctor
IRCCS Policlinico S. Donato
