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OpenTrials
Completed

NCT Number: NCT01560910

Detection of Minimal Change Esophagitis by I-scan

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.

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Key information

Conditions

Gastro-esophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Non-Erosive Reflux Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Maharaj Nakorn Chiangmai Hospital

Chiang Mai, Thailand

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnancy,
  • cirrhosis or presence of gastroesophageal varices,
  • gastrointestinal hemorrhage,
  • angina pectoris,
  • allergy to PPI,
  • high risk or contraindication for endoscopy,
  • chronic cough,laryngitis, asthma.

Sponsors and collaborators

Lead sponsor

arpa pungrasamee

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 22, 2012
Registry last updated
Mar 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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