Combined Magnetic Resonance Imaging and High Resolution Manometry Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Gastro-oesophageal insertion angle, contact span (of stomach on oesophagus)
研究概览
简要总结
Aims of research project:
To identify key features of the gastro-esophageal junction (structure and function) that protects the esophagus from gastro-esophageal reflux investigated by combined high resolution manometry and magnetic resonance imaging.
Hypothesis:
- Functional factors including GEJ function (e.g. sphincter pressure) and proximal gastric distension determine whether or not TLESR occurs; however
- Structural factors including separation of GEJ anatomy, intra-gastric distribution of the meal and secretions determine whether TLESR is accompanied by no reflux event, gas reflux (belching) or reflux of ingested food and gastric secretion ('true reflux').
- Initial findings by descriptive studies in healthy volunteers (study #1) and patients with mild to moderate gastro-esophageal reflux disease (study #2) will be further interrogated by a randomized, double-blind control trial of baclofen in patients with GORD; a medication that inhibits reflux by effects on GOJ function (study #3) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Baclofen
Baclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement)
干预措施: Baclofen (Drug)
Placebo
Placebo suspension (single dose 90 minutes prior to physiologic measurement)
干预措施: Placebo (Drug)
结局指标
主要结局
Gastro-oesophageal insertion angle, contact span (of stomach on oesophagus)
时间窗: Pre- and post-meal ingestion
Gastro-oesophageal morphology from MRI imaging: insertion angle, contact span (of stomach on oesophagus) assessed from 3D models of stomach reconstructed from MRI imaging
次要结局
- gastric accommodation(post-meal)
- gastric emptying(post-meal)
- number of reflux events(post-meal)
