Comprehensive Analysis of the Swallowing Mechanism Using High-resolution Manometry With Impedance
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- University Hospital Ostrava
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- PAET (Proximal Acid Exposure Time)
概览
简要总结
The aim of this project is to perform a detailed evaluation of upper esophageal sphincter function and the swallowing mechanism in patients with swallowing disorders or suspected extraesophageal reflux using high-resolution manometry with impedance and 24-hour pH-impedance monitoring.
详细描述
The project seeks to improve diagnostic accuracy, identify functional abnormalities that are not detectable by conventional diagnostic methods, and establish a foundation for more effective and targeted therapeutic strategies.
The upper esophageal sphincter (UES) represents a crucial functional structure at the junction of the digestive and respiratory tracts. Its proper function is essential for the coordination of the swallowing process and for the protection of the upper airways. Disorders of the UES may be associated with a wide range of otorhinolaryngological symptoms, including dysphagia, globus pharyngeus, chronic cough, hoarseness, laryngeal dysfunction, and voice disorders. Modern diagnostic techniques, such as 24-hour esophageal impedance monitoring and high-resolution manometry (HRM), enable detailed assessment of gastroesophageal reflux and esophageal pressure dynamics, thereby offering new possibilities for the diagnosis and understanding of these conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
No masking will be used in the study.
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
- •age 18-75 years
- •patients with swallowing difficulties suspected of having a functional oesophageal disorder or patients with clinical signs of extra-oesophageal reflux (Reflux Symptom Index \[RSI\] ≥ 13 or Reflux Symptom Score-12 \[RSS-12\] ≥ 11) signed informed consent
排除标准
- •patients with a diagnosed tumor of the esophagus or upper airway, or with strong clinical suspicion of a tumor of the esophagus or upper airway
- •severe neurological disease affecting swallowing
- •pregnancy
- •surgery involving the head, neck, or esophagus within the last 6 months
研究组 & 干预措施
Extraoesophageal reflux
Patients with extraoesophageal reflux will be enrolled in this study arm.
干预措施: High resolution oesophageal manometry with impedance (Diagnostic Test)
Extraoesophageal reflux
Patients with extraoesophageal reflux will be enrolled in this study arm.
干预措施: 24-hour pH metry (Diagnostic Test)
Dysphagia
Patients with dysphagia reflux will be enrolled in this study arm.
干预措施: High resolution oesophageal manometry with impedance (Diagnostic Test)
结局指标
主要结局
PAET (Proximal Acid Exposure Time)
时间窗: 24 hours
PAET (Proximal Acid Exposure Time) - acid exposure to the proximal oesophageus will be measured in per cent of the whole 24-h period.
Upper esophageal sphincter (UES) Integrated Relaxation Pressure (IRP)
时间窗: 15 minutes
UES IRP is a measure of the extent of UES relaxation measured in mmHg
UES Maximum Admittance
时间窗: 15 minutes
UES MaxAd is the highest admittance value recorded during trans-sphincteric bolus flow measured in milliseconds.
次要结局
未报告次要终点