Detection of Minimal Change Esophagitis by I-scan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
arpa pungrasamee, Maharaj Nakorn Chiang Mai Hospital
ClinicalTrials.gov Identifier:
NCT01560910
First received: March 20, 2012
Last updated: March 21, 2012
Last verified: March 2012
  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

Resource links provided by NLM:


Further study details as provided by 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560910

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

No publications provided

Responsible Party: arpa pungrasamee, Doctor, Maharaj Nakorn Chiang Mai Hospital
ClinicalTrials.gov Identifier: NCT01560910     History of Changes
Other Study ID Numbers: ISSNEXI0018
Study First Received: March 20, 2012
Last Updated: March 21, 2012
Health Authority: Thailand: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on April 23, 2014