Characterization of Lower Esophageal Sphincter Function in Idiopathic Esophagogastric Junction Outflow Obstruction and Clinical Response to Pneumatic Dilation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Brief esophageal dysphagia questionnaire (BEDQ)
研究概览
简要总结
This study compares two treatments for Idiopathic Esophagogastric Junction Outflow Obstruction: pneumatic dilation compared with expectant management, on symptoms and liquid barium emptying exams.
详细描述
The objectives of this study are to address these gaps in knowledge by:
Performing a randomized controlled trial in patients with idiopathic EGJOO that compares treatment outcomes after pneumatic dilation versus expectant management (disease controls) (expectant management). And, determining rational physiological and objective measures of treatment response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Initial HRIM consistent with the diagnosis of EGJOO and mechanical esophageal obstruction has been excluded by prior upper endoscopy.
- •EGJOO patients with a retained liquid barium column on TBE ≥5cm in height at 1 minute
- •Patients must have symptomatic dysphagia
排除标准
- •Diseases that potentially could cause mechanical obstruction such as gastroesophageal reflux disease with erosive esophagitis, peptic stricture, cancer, eosinophilic esophagitis, prior fundoplication, adjustable gastric band surgery and hiatal hernias. Patients with any identifiable anatomic esophageal or gastric obstruction will be excluded from the study
- •Patients with previous surgery on the esophagus or stomach
- •Previous history of per oral endoscopic myotomy or prior pneumatic dilation
- •History of gastroparesis
结局指标
主要结局
Brief esophageal dysphagia questionnaire (BEDQ)
时间窗: 6 months
The BEDQ is a 10-item self-report measure of dysphagia symptoms. The questionnaire is scored on a scale of 0-40. Higher scores indicate greater severity and frequency of dysphagia symptoms.
Eckardt Score
时间窗: Week 6
The Eckardt score is the grading system most frequently used for the evaluation of symptoms and efficacy of achalasia treatment. 33 It attributes points (0-3 points) to 4 symptoms of the disease (dysphagia, regurgitation, chest pain, and weight loss), and its total ranges from 0-12. The higher the score the worse the symptoms.
Number of participants with retained barium column ≥5cm
时间窗: Week 6
Measured in the timed barium esophagram
次要结局
未报告次要终点