Trans-Cervical and Trans-abdominal Ultrasound for Monitoring Esophageal Thickness in Eosinophilic Esophagitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Correlation between US-measured esophageal thickness and Eosinophilic Esophagitis Endoscopic Reference Score / histological eosinophil counts.
研究概览
简要总结
Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease characterized by eosinophilic infiltration of the esophageal mucosa, leading to symptoms of dysphagia and food impaction. Currently, upper endoscopy with biopsy is the gold standard for diagnosis and disease monitoring, but it is invasive, costly, and associated with procedural risks. The investigators want to use ultrasound imaging as a non-invasive assessment of esophageal wall thickness as a surrogate marker for mucosal inflammation.
Participants will undergo ultrasound assessment at the same day of endoscopy, and than after 3-6 months (optional). The correlation between US-measured esophageal thickness and histological eosinophil counts will be measured.
详细描述
Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease characterized by eosinophilic infiltration of the esophageal mucosa, leading to symptoms of dysphagia and food impaction. Currently, upper endoscopy with biopsy is the gold standard for diagnosis and disease monitoring, but it is invasive, costly, and associated with procedural risks.
Recent advances in ultrasound (US) imaging suggest the potential for non-invasive assessment of esophageal wall thickness as a surrogate marker for mucosal inflammation. This study aims to evaluate the efficacy and accuracy of trans-cervical/abdominal ultrasound in assessing esophageal thickness compared to the conventional endoscopic evaluation in patients with suspected or confirmed EoE. If validated, this approach could significantly reduce patient burden and reliance on frequent invasive procedures.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Suspected or confirmed diagnosis of EoE based on clinical symptoms (e.g., dysphagia, food impaction).
- •Scheduled for upper endoscopy with biopsies.
- •Able and willing to consent to participation.
排除标准
- •Prior esophageal surgery or anatomical abnormalities.
- •Presence of other gastrointestinal disorders affecting the esophagus (e.g., esophageal cancer, achalasia, Barrett's esophagus).
- •Pregnancy.
- •Inability to undergo US due to anatomical or physical limitations.
结局指标
主要结局
Correlation between US-measured esophageal thickness and Eosinophilic Esophagitis Endoscopic Reference Score / histological eosinophil counts.
时间窗: 6 months
Comparison of ultrasound results and histological results of eosinophils. Esophagitis Endoscopic Reference score scale: Fixed rings: 0-3, Exudates: 0-2, Furrows: 0-2, Oedema: 0-2, Stricture: 0-1, Feline esophagus: 0-1, Narrow calibre esophagus: 0-1, Crepe paper esophagus: 0-1. Higher scores mean a worse outcome.
次要结局
未报告次要终点