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临床试验/NCT03306485
NCT03306485已完成不适用

Evaluation of Diagnostic Performances of Esophageal Post Prandial High Resolution Impedance- Manometry (HRIM) in Patients With Gastro-esophageal Reflux Disease (GERD) Resistant to Proton Pump Inhibitor (PPI) Treatment : Pilot Study (MHR POST-PRANDIALE)

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2017年12月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
24-h pH-impedance

研究概览

简要总结

Nine to 30% of the population suffers from gastro-esophageal reflux disease (GERD) - suggestive symptoms (heartburn, regurgitation, chest pain, chronic couch, sore throat). Proton pump inhibitor (PPI) is usually the first line treatment. However 20 to 60% of patients have persistent symptoms on proton pump inhibitor. Complementary examinations are then required to determine the cause of persistent symptoms (non compliance to treatment, persistent esophageal acid exposure despite proton pump inhibitor, non acid reflux, reflux hypersensitivity, functional symptoms, rumination syndrome...). The gold standard to detect reflux episodes in patients on proton pump inhibitor therapy is 24-h ambulatory esophageal pH-impedance monitoring. Esophageal High Resolution Impedance-Manometry might help to determine gastro-esophageal reflux disease mechanisms especially when performed post prandially. Further some publications demonstrated that the number of reflux episodes detected during the post prandial period might be well correlated to the total number of reflux episodes recorded during 24 h.

The hypothesis of this study is that 1-hour post prandial esophageal High Resolution Impedance-Manometry might be useful to diagnose gastro-esophageal reflux disease and can replace in some instances 24-h esophageal pH-impedance monitoring. Therefore the aim is to compare the number of reflux episodes detected with esophageal High Resolution Impedance-Manometry performed during 1-h post prandial period to the total number of reflux episodes detected during 24-h ambulatory esophageal pH-impedance monitoring.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient of both gender older than 18 years
  • Patient referred for post prandial esophageal high resolution manometry combined with impedance and ambulatory 24-h pH-impedance monitoring on proton pump inhibitor
  • Heartburn and/or regurgitation despite double dose proton pump inhibitor therapy
  • Proven Gastro-esophageal reflux disease off proton pump inhibitor (Los Angeles grade B, C or D esophagitis and/or esophageal acid exposure > 5% on esophageal pH monitoring off proton pump inhibitor)
  • Absence of major esophageal motility disorders (achalasia, esophago-gastric junction outflow obstruction, esophageal spasm, jackhammer esophagus, absent contractions)
  • Patient who does not decline to participate to the study

排除标准

  • Patient younger than 18 years
  • Pregnancy or breast feeding
  • Previous history of esophago-gastric surgery ( including anti-reflux surgery, Heller myotomy, bariatric surgery)
  • Patient with severe renal insufficiency
  • Patient with severe cardiac insufficiency
  • Patient legally incompetent or unable to give consent
  • Patient who declines to participate to the study
  • Participation to another study at the same time

结局指标

主要结局

24-h pH-impedance

时间窗: 24 hour

Number of reflux episodes detected on 24-h ambulatory esophageal pH-impedance monitoring

High Resolution Impedance Manometry

时间窗: 1 hour

Number of reflux episodes detected on high resolution impedance manometry during the one hour following the meal

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Post Prandial High Resolution Impedance- Manometry | 临床试验