Detection of Minimal Change Esophagitis by I-scan

Completed

• Conditions: Gastro-esophageal Reflux Disease; Non-erosive Reflux Disease

• Registration Number: NCT01560910
• Lead Sponsor: arpa pungrasamee

Brief Summary

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.

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.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-03
• Study First Submitted: 2012-03-20
• Study First Submitted QC: 2012-03-21
• Last Update Submitted: 2012-03-21
• Study First Posted: 2012-03-22
• Last Update Posted: 2012-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Maharaj Nakorn Chiangmai Hospital; 🇹🇭 Chiangmai, Thailand