24 Hour Esophageal and Electrogastrography to Investigate the Mechanism of Reflux Esophagitis
NCT ID: NCT00154570
Last Updated: 2005-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2004-02-29
2005-08-31
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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DEFINED_POPULATION
OTHER
Interventions
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EGG, 24 hour esophageal pH monitor
Eligibility Criteria
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Inclusion Criteria
* Endoscopic esophagitis.
Exclusion Criteria
* Gastric or esophageal cancer.
* Esophageal varices.
* Concomittant severe systemic disease.
18 Years
85 Years
ALL
Yes
Sponsors
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National Taiwan University Hospital
OTHER
Principal Investigators
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Bor-Ru Lin, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Jau-Min Wong, M.D. & Ph.D.
Role: primary
Other Identifiers
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9261701469
Identifier Type: -
Identifier Source: org_study_id