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Detection of Minimal Change Esophagitis by I-scan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560910
First Posted: March 22, 2012
Last Update Posted: March 22, 2012
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.
Information provided by (Responsible Party):
arpa pungrasamee, Maharaj Nakorn Chiang Mai Hospital
  Purpose
Study design and objective The primary outcome of this prospective cohort study was to identify the endoscopic findings that have diagnostic value for the prediction of NERD (minimal change esophagitis) by using HD endoscopy with i-scan. The secondary outcome was to evaluate the response to proton pump inhibitor (PPI) in GERD patients with or without minimal change esophagitis.

Condition
Gastro-esophageal Reflux Disease Non-erosive Reflux Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by arpa pungrasamee, Maharaj Nakorn Chiang Mai Hospital:

Enrollment: 48
Study Start Date: January 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Background and aims Majority of patients with gastro-esophageal reflux disease (GERD) were non-erosive reflux disease (NERD). High definition (HD) endoscopy with i-scan could enhance visualization of mucosal and vascular pattern and might identify changes that were invisible at standard endoscopy. This study aimed to evaluate the endoscopic findings that may have diagnostic value for the prediction of NERD by using HD endoscopy with i-scan.

Methods Patients with typical GERD symptoms and healthy control without GERD symptoms were included and 2 validated GERD questionnaires were completed. The endoscopist was blinded to the presence of reflux symptoms and distal esophagus was examined using standard white light endoscopy followed by i-scan. Mucosal morphology at squamocolumnar junction (SCJ) observed by i-scan were compared between GERD patients and controls.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population

The patients with or without GERD symptoms presenting to gastrointestinal clinic of Maharaj Nakorn Chiangmai Hospital from November 2009 to November 2010 were invited to participate in this study. All patients completed 2 validated questionnaires (RDQ: reflux diagnostic questionnaire and HRQL: Health-related quality-of-life GERD questionnaire) after giving written informed consent. Patients were enrolled if they were 18 to 80 years of age and had ability to provide written informed consent.

Patients who have heartburn or regurgitation more than 2 times/week for at least 1 month were defined as having GERD and patient without any reflux symptoms served as controls.The exclusion criteria were 1) pregnancy, 2) cirrhosis or presence of gastroesophageal varices, 3) gastrointestinal hemorrhage, 4) angina pectoris, 5) allergy to PPI, 6) high risk or contraindication for endoscopy, 7) chronic cough, laryngitis, asthma.

Criteria

Inclusion Criteria:

18 to 80 years of age and had ability to provide written informed consent

Exclusion Criteria:

  1. pregnancy,
  2. cirrhosis or presence of gastroesophageal varices,
  3. gastrointestinal hemorrhage,
  4. angina pectoris,
  5. allergy to PPI,
  6. high risk or contraindication for endoscopy,
  7. chronic cough,laryngitis, asthma.
  Contacts and Locations
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): NCT01560910


Locations
Thailand
Maharaj Nakorn Chiangmai Hospital
Chiangmai, Thailand
Sponsors and Collaborators
arpa pungrasamee
  More Information

Responsible Party: arpa pungrasamee, Doctor, Maharaj Nakorn Chiang Mai Hospital
ClinicalTrials.gov Identifier: NCT01560910     History of Changes
Other Study ID Numbers: ISSNEXI0018
First Submitted: March 20, 2012
First Posted: March 22, 2012
Last Update Posted: March 22, 2012
Last Verified: March 2012

Keywords provided by arpa pungrasamee, Maharaj Nakorn Chiang Mai Hospital:
with or without GERD symptoms
presenting to gastrointestinal clinic of Maharaj Nakorn Chiangmai Hospital
November 2009 to November 2010
GERD
NERD

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases