Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

24 Hour Esophageal and Electrogastrography to Investigate the Mechanism of Reflux Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00154570
Recruitment Status : Unknown
Verified February 2004 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : November 22, 2005
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:
We hypothesize that gastric dysrhythmias may predispose the occurrence of gastroesophageal reflux.

Condition or disease Intervention/treatment
Reflux Esophagitis Device: EGG, 24 hour esophageal pH monitor

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 > 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).

Layout table for study information
Study Type : Observational
Enrollment : 50 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Integrating Simultaneous Recording of 24 Hour Esophageal pH and Electrogastrography to Investigate the Mechanism of Reflux Esophagitis
Study Start Date : February 2004
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • GERD questionnaire with heartburn or acid regurgitation with a frequency at least once weekly.
  • Endoscopic esophagitis.

Exclusion Criteria:

  • A history of esophageal, gastric or abdominal surgery.
  • Gastric or esophageal cancer.
  • Esophageal varices.
  • Concomittant severe systemic disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154570


Contacts
Layout table for location contacts
Contact: Bor-Ru Lin, M.D. 886-2-23123456 ext 7788 brlin@ha.mc.ntu.edu.tw
Contact: Jau-Min Wong, M.D. & Ph.D. 886-2-23123456 ext 5696 jmwong@ha.mc.ntu.edu.tw

Locations
Layout table for location information
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10016
Contact: Jau-Min Wong, M.D. & Ph.D.    886-2-23123456 ext 5696    jmwong@ha.mc.ntu.edu.tw   
Principal Investigator: Bor-Ru Lin, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Bor-Ru Lin, M.D. National Taiwan University Hospital

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00154570     History of Changes
Other Study ID Numbers: 9261701469
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: November 22, 2005
Last Verified: February 2004

Keywords provided by National Taiwan University Hospital:
reflux esophagitis
24 hour esophageal pH
electrogastrography (EGG)
Running Spectral Analysis (RSA)

Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Esophagitis
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases