Reflux Esophagitis Clinical Trial
Official title:
Integrating Simultaneous Recording of 24 Hour Esophageal pH and Electrogastrography to Investigate the Mechanism of Reflux Esophagitis
We hypothesize that gastric dysrhythmias may predispose the occurrence of gastroesophageal reflux.
Gastroesophageal regurgitation with acid is considered the main cause of reflux esophagitis,
but the current theory of transient relaxation of LES (TLESR) fails to explain all the
mechanisms of reflux esophagitis, for a rather high proportion of reflux esophagitis
patients has concomitant other functional gastrointestinal disorder, particularly gastric
motility dysfunction. Thus, these patients could even not effectively respond to proton pump
inhibitor alone. Abnormal gastric emptying and antral dysmotility has been considered
related to reflux esophagitis. EGG is a promising noninvasive tool in study of gastric
electric activity and motility, and the application of gastric electric stimulation (GES) in
the modulation of gastric motility disorder and even reflux esophagitis has been in
proceeding; however, there is lacking study by using EGG to integrate gastric electrical
potentials, gastric motility and gastroesophageal reflux in investigating the mechanism of
reflux esophagitis till now; especially, no known literature by combined simultaneous
prolong ambulatory esophageal pH and EGG recordings has been reported. It has been known in
EGG study that gastric dysrhythmias (tachy- and brady-) related smooth muscle function of
stomach and dysfunctional gastric emptying.
In a preliminary findings of simultaneous prolong ambulatory esophageal pH and EGG
recordings by our study group, we found that gastroesophageal reflux with acid tends in the
status of abnormal RSA. Thus, we propose the following hypotheses: (1) Gastric dysrhythmias
may predispose the occurrence of gastroesophageal reflux. We plan to use the recorder of
esophageal pH and gastric electric potentials developed in Institute of Medical Engineering,
National Taiwan University, combining with the unique design of simultaneous 24 hour
ambulatory esophageal pH and EGG recordings and Matlab analysis of RSA-pH, to explore the
relationship of gastric electric potentials and reflux esophagitis.
Objectives: (1) Use simultaneous 24 hour ambulatory esophageal pH metry and EGG to integrate
RSA and esophageal pH to explore whether a specific RSA prone to gastroesophageal reflux; or
whether gastroesophageal reflux influence gastric electric activity; (2) Integrate RSA and
esophageal pH with event of GI symptoms and daily activity to explore whether symptoms are
resulted from acid reflux or gastric dysrhythmias.
Materials and methods: Recruits 25 healthy and 25 previously diagnosed reflux esophagitis
patients as volunteers to receive the followings:
1. GI and GERD symptom questionnaire with score of severity and frequency, and quality of
life (QoL).
2. 24-hour ambulatory esophageal pH recording: total numbers of reflux episodes, total
duration of pH < 4 and DeMester score. They will be classified into: pathologic (pH <
4, > 4%且DeMeester score > 14.72 ) and non-pathologic (pH < 4, < 4% and DeMeester score
< 14.72).
3. 24-hour ambulatory EGG recording: Use RSA to evaluate the quantity and quality of
gastric electrical potentials. They will be classified into normal (3cpm),
tachyrhythmia (> 3cpm), and bradyrhythmia (< 3cpm) three groups.
4. Use Matlab soft ware to integrate the data of simultaneous 24-hour esophageal pH value
and RSA with events of symptoms and daily activities (meal time, postprandial, fasting,
sleeping, and exercise).
;
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional
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