Structure and Function of the Gastro-esophageal Junction
2011年6月1日 更新者:University of Zurich
Combined Magnetic Resonance Imaging and High Resolution Manometry Studies
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) .
研究概览
研究类型
介入性
注册 (实际的)
24
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
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Zurich、瑞士、CH-8091
- Division of Gastroenterology
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-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria:
Study #1:
- healthy male and female volunteers
- aged at least 18 and not more than 49 y
- no history of gastrointestinal symptoms
- able to communicate well with the investigators and to comply with the requirements for the entire study
- who provided written informed consent before participating in the study, after being given a full description of the trail.
Study #2 and #3:
- male and female patients with mild to moderate gastro-oesophageal reflux disease defined by presence of (1) reflux symptoms (2) pathological esophageal acid exposure between 5-10% on 24 hour ambulatory testing
- aged at least 18 and not more than 49 y
- no history of gastrointestinal symptoms
- able to communicate well with the investigators and to comply with the requirements for the entire study
- who provided written informed consent before participating in the study, after being given a full description of the trail.
Exclusion criteria:
- with present psychiatric disorders or mental impairment limiting the ability to comply with study requirements
- with use of medications influencing upper GI motility within one week of the study (i.e. beta- blocker, calcium channel blockers, nitrates, prokinetic drugs, macrolide antibiotics)
- with regular intake of medication; occasional use of analgesic e.g. aspirin, paracetamol is allowed
- with symptoms or a history of gastrointestinal disease other than gastro-esophageal reflux disease (in study #2 and #3)
- suffering from known liver, kidney, cardiovascular, neurological or pulmonary disease
- with any evidence of infectious disease
- with evidence or history of drug or alcohol abuse
- with insufficient knowledge of the German language • who, for any reason, are unable to complete the study
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Baclofen
Baclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement)
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Baclofen suspension 40mg (single dose 90 minutes prior to physiologic measurement)
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|
安慰剂比较:Placebo
Placebo suspension (single dose 90 minutes prior to physiologic measurement)
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Placebo single 'dose' 90 minutes prior to study
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Gastro-oesophageal insertion angle, contact span (of stomach on oesophagus)
大体时间:Pre- and post-meal ingestion
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Gastro-oesophageal morphology from MRI imaging: insertion angle, contact span (of stomach on oesophagus) assessed from 3D models of stomach reconstructed from MRI imaging
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Pre- and post-meal ingestion
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
gastric emptying
大体时间:post-meal
|
dynamic change in gastric and meal volumes over course of study assessed from MRI imaging.
gastric emptying assessed from complete data set
|
post-meal
|
|
gastric accommodation
大体时间:post-meal
|
dynamic change in gastric and meal volumes over course of study assessed from MRI imaging.
gastric accommodation assessed from complete data set
|
post-meal
|
|
number of reflux events
大体时间:post-meal
|
assessed by presence of common cavity events on (high resolution) manometry
|
post-meal
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年2月1日
初级完成 (实际的)
2011年5月1日
研究完成 (实际的)
2011年5月1日
研究注册日期
首次提交
2009年7月21日
首先提交符合 QC 标准的
2010年1月20日
首次发布 (估计)
2010年1月21日
研究记录更新
最后更新发布 (估计)
2011年6月2日
上次提交的符合 QC 标准的更新
2011年6月1日
最后验证
2011年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.