Benefit of Pharyngeal and Oesophageal pH-impedance of Patients With High Suspicion of Laryngopharyngeal Reflux
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of pharyngeal reflux/24h
研究概览
简要总结
Laryngopharyngeal reflux (LPR) is the retrograde movement of gastric contents into the larynx, pharynx and upper aerodigestive tract. The symptoms and manifestations are very changeable and non specific. Pharyngeal and Oesophageal pH-impedance may help to detect these reflux and to identify patients with abnormal LPR.
To compare and describe the results of pharyngeal and oesophageal pH-impedance of patients with high suspicion of laryngopharyngeal reflux, with the results of healthy patients.
详细描述
This is a monocentric, prospective descriptive study. Patients will be recruited in otolaryngology and gastroenterology departments of Bordeaux teaching hospital. A first clinical, endoscopic and pH-impedance evaluation will be made, after at least 15 days of interruption of any proton pump inhibitors (PPI). After 8 weeks' treatment by double PPI doses (esomeprazole 40 mg bid), another clinical and pH-impedance evaluation will be realized. The characteristics of the patients who respond to the treatment will be compared to non responders. The subjects will also have an initial laryngoscopy, an oesophageal manometry allowing the location of the lower sphincter of the oesophagus and the upper sphincter of the oesophagus for positioning the catheters.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age : 18 to 80 years old.
- •Written consent
- •Laryngopharyngeal symptoms (dysphonia, and/or globus and/or sensation, and/or pharyngeal pain, and/or cough) for 3 months at least.
- •No PPI for at least 15 days
- •Social security affiliation
排除标准
- •Sinusitis or chronic rhinitis (in the previous year)
- •Laryngeal trauma, tracheotomy or pharyngolaryngeal surgery
- •pregnancy or absence of efficacy contraception
- •breast feeding
- •history of gastrointestinal pathology, diabetes, neurological condition
- •cardio-vascular history requiring the taking of Plavix
- •esomeprazole contraindication or intolerance
研究组 & 干预措施
Patient
干预措施: esomeprazole (Drug)
结局指标
主要结局
Number of pharyngeal reflux/24h
时间窗: visit 3 - 60 days after inclusion
• Pharyngeal acid exposure (% of total time with pharyngeal pH <4)
时间窗: Visit 3 - 60 days after inclusion
• Number of pharyngeal acid reflux/24h
时间窗: Visit 3 - 60 days after inclusion
• Number of pharyngeal less acid reflux/24h
时间窗: Visit 3 - 60 days after inclusion
• Pharyngeal bolus exposure (% of total time with liquid in the pharynx)
时间窗: Visit 3 - 60 days after inclusion
次要结局
未报告次要终点