Detection of Minimal Change Esophagitis by I-scan

Non-erosive Reflux Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560910
• Other study ID #: ISSNEXI0018
• Status: Completed
• Phase: N/A
• First received: March 20, 2012
• Last updated: March 21, 2012
• Start date: January 2010
• Est. completion date: December 2010

Study information

• Verified date: March 2012
• Source: Maharaj Nakorn Chiang Mai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastro-esophageal Reflux Disease
• Gastroesophageal Reflux
• Non-erosive Reflux Disease

Locations

Country	Name	City	State
Thailand	Maharaj Nakorn Chiangmai Hospital	Chiangmai

Sponsors (1)

Lead Sponsor	Collaborator
arpa pungrasamee

Country where clinical trial is conducted

Thailand,