Diagnostic of Transient Lower Esophageal Sphincter Relaxation With Combined Impedance and High Resolution Manometry in Patients With GERD.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 6
- 主要终点
- tLESRs characteristics
研究概览
简要总结
The aim of this study is to establish and validate High resolution manometry (HRM) criteria for the definition of transient lower esophageal sphincter relaxations (tLESRs) in gastroesophageal reflux disease (GERD) patients.
详细描述
tLESRs represent the main mechanism of all types of reflux events. Inhibition of transient lower esophageal sphincter relaxations (tLESRs) has become one of the most relevant therapeutic objectives in patients with reflux symptoms resistant to proton pump inhibitors. HRM is the gold standard for detecting and characterizing tLESR, and could be considered as part of the pharmacological evaluation of new drugs targeting tLESRs. HRM criteria for the objective definition of tLESRs in GERD patients have to be established, as it has been done in healthy patients Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.
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
- •Patients 18 to 75 years old
- •GERD documented by :
- •Typical reflux symptoms (heartburn, regurgitations) completely responsive to PPI therapy
- •And/or erosive esophagitis or Barrett's esophagus at endoscopy
- •And/or positive pH 24h monitoring (acid exposure time > 5% or positive symptom association indices)
- •Possibility of easily positioned transnasal catheter
- •Patients covered by social security
- •Subjects must provide written, free and informed consent
排除标准
- •Pregnant or lactating women
- •History of digestive or thoracic surgery (except appendicectomy)
- •Patients unable to stop PPI therapy for 7 days
- •Subjects unable to provide written consent, including adult under guardianship and emergency situation
- •Simultaneous participation in another study
结局指标
主要结局
tLESRs characteristics
时间窗: Inclusion (Day 0)
To characterize tLESRs defined according following criteria: * LES basal pressure (mmHg) defined as LES pressure during relaxation * LES minimum pressure during relaxation * Duration of the LES relaxation (seconds) * Integrated relaxation pressure (4 seconds)
Reflux underlying mechanisms
时间窗: Inclusion (Day 0)
To detect every reflux and to determine underlying mechanisms * Transient lower esophageal sphincter relaxations (tLESR) * Low basal LES pressure (free reflux) * Increased abdominal pressure * Swallow * Another mechanism
次要结局
未报告次要终点