Reflux EsophagitisNCT00154570
24 Hour Esophageal and Electrogastrography to Investigate the Mechanism of Reflux Esophagitis
An observational study of Reflux Esophagitis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
We hypothesize that gastric dysrhythmias may predispose the occurrence of gastroesophageal reflux. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Reflux Esophagitis
- What is being tested?
- EGG, 24 hour esophageal pH monitor
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2004to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- GERD questionnaire with heartburn or acid regurgitation with a frequency at least once weekly.
- Endoscopic esophagitis.
Who cannot join
- A history of esophageal, gastric or abdominal surgery.
- Gastric or esophageal cancer.
- Esophageal varices.
- Concomittant severe systemic disease.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10016
Jau-Min Wong, M.D. & Ph.D., 886-2-23123456 ext. 5696, jmwong@ha.mc.ntu.edu.tw
Bor-Ru Lin, M.D.
About this study
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.
Read the 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:
- GI and GERD symptom questionnaire with score of severity and frequency, and quality of life (QoL).
- 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).
- 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.
- 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
- Reflux Esophagitis
- Being tested
- EGG, 24 hour esophageal pH monitor
- Keywords
- reflux esophagitis, 24 hour esophageal pH, electrogastrography (EGG), Running Spectral Analysis (RSA)
- Medical subject headings
- Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGG, 24 hour esophageal pH monitorDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflux EsophagitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Bor-Ru Lin, M.D., Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00154570
- Sponsor's protocol ID
- 9261701469
- Status last verified
- Feb 2004
- First submitted
- 9 Sep 2005
- Last updated
- 22 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Simultaneous Recording of 24 Hour Esophageal pH and Electrogastrography to Investigate the Mechanism of Reflux Esophagitis
- ClinicalTrials.gov ID
- NCT00154570
- Acronym / sponsor ID
- 9261701469
- Conditions
- Reflux Esophagitis
- Keywords
- reflux esophagitis, 24 hour esophageal pH, electrogastrography (EGG), Running Spectral Analysis (RSA)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2004
- Study completion
- Aug 2005
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- GI and GERD symptom questionnaire with score of severity and frequency, and quality of life (QoL).
- 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).
- 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.
- 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 design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- GERD questionnaire with heartburn or acid regurgitation with a frequency at least once weekly.
- Endoscopic esophagitis.
Key exclusion criteria (4 listed)
- A history of esophageal, gastric or abdominal surgery.
- Gastric or esophageal cancer.
- Esophageal varices.
- Concomittant severe systemic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGG, 24 hour esophageal pH monitor | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bor-Ru Lin, M.D. principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reflux Esophagitis, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bor-Ru Lin, M.D. (886-2-23123456 ext. 7788, brlin@ha.mc.ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2005.