Transient Lower Esophageal Sphincter Relaxations Detection Using High Resolution Manometry. Validation in Healthy Volunteers.
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- The primary outcome is to demonstrate that high resolution manometry allows the detection of meal-induced tLESr. All recordings will be analyzed at the end of each examination and reviewed at the end of the enrolment.
研究概览
简要总结
Transient lower esophageal sphincter relaxations (tLESr) are the main mechanism of gastro-oesophageal reflux disease. They occur without any deglutition in patients but also in healthy volunteers. They are induced by meal.
The gold standard to detect tLESr is esophageal manometry using perfused Dentsleeve probe.
Esophageal high resolution manometry with solid state sensors was developed in the 90s. The examination is easier and more accurate than perfused manometry. The aim of this study is to validate in healthy volunteers the use of high resolution manometry (Sierra Scientific Instruments, California CA) to detect tLESr.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female between 18 and 60 years
- •Subject without typical or atypical symptoms of gastro-esophageal reflux disease (heartburn, regurgitation, epigastric pain, chest pain, chronic cough, pharyngeal pain)
- •Subject without any medication (except oral contraception)
- •Subject without previous digestive surgery history (except appendicectomy)
- •Capability to pass manometric probes through each nostril
- •Subject with health insurance
- •Written informed consent
- •No participation to another study at the same time
排除标准
- •Age under 18 years or upper 60
- •Pregnant woman or lactation
- •Incapability to give consent
- •No written informed consent
结局指标
主要结局
The primary outcome is to demonstrate that high resolution manometry allows the detection of meal-induced tLESr. All recordings will be analyzed at the end of each examination and reviewed at the end of the enrolment.
次要结局
- To compare the number of tLESr detected by high resolution manometry and those detected by manometry with perfused dentsleeve probe.
- To define the characteristics (duration, relaxation amplitude) of high resolution manometry-detected tLESr.