Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00154570
Status:
UNKNOWN
Last Update Posted:
2005-11-22
First Post:
2005-09-09
Brief Title:
24 Hour Esophageal and Electrogastrography to Investigate the Mechanism of Reflux Esophagitis
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Integrating Simultaneous Recording of 24 Hour Esophageal pH and Electrogastrography to Investigate the Mechanism of Reflux Esophagitis
Status:
UNKNOWN
Status Verified Date:
2004-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We hypothesize that gastric dysrhythmias may predispose the occurrence of gastroesophageal reflux
Detailed Description:
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 1472 and non-pathologic pH 4 4 and DeMeester score 1472
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
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 1472 and non-pathologic pH 4 4 and DeMeester score 1472
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None