NCT01284894已完成不适用
Diagnostic Yield of Esophageal High Resolution Manometry in Patients With Unexplained Dysphagia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 2
- 主要终点
- Percentage of patients correctly diagnosed for esophageal motility disorder
研究概览
简要总结
Two to 15% of subjects present dysphagia. In case of normal eso-gastro-duodenal endoscopy, patients with dysphagia are referred for esophageal motility testing. Esophageal manometry is the gold standard to evaluate esophageal motility in absence of esophageal obstruction. Two different techniques are available: the conventional manometry and the high resolution manometry. The second one may improve the diagnostic yield and the tolerance of examination in patients with dysphagia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male or female older than 18 years
- •Patient with unexplained dysphagia
- •Patient without cause of dysphagia on eso-gastro-duodenal endoscopy
- •Patient referred for esophageal manometry
- •Patient with health insurance
- •Informed consent signed
排除标准
- •Patient younger than 18 years
- •Allergy to one component of manometry catheter
- •Drug intake which can modify the esophageal motricity within 12 hours preceding the realization of the manometry
- •Patient unable to give his consent or legally incompetent
- •Patient non qualified according to the investigator
- •Patient refusal or absence of informed consent signed
- •Concomitant participation to another study
结局指标
主要结局
Percentage of patients correctly diagnosed for esophageal motility disorder
时间窗: 6 months
次要结局
- Tolerability (pain, nausea, cough, anxiety) and side effects (nasal bleeding, vomiting, inhalation, esophageal perforation, cardiac failure)(24 hours)
- Duration of examination and study analysis(day 0)
- Cost of patient care within the 6 months following the manometry(6 months)
研究者
研究点 (2)
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