Detection of Minimal Change Esophagitis by I-scan

NCT01560910 | Completed

• 1 other identifier: ISSNEXI0018
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastro-esophageal Reflux Disease; Non-erosive Reflux Disease

Keywords

with or without GERD symptoms; presenting to gastrointestinal clinic of Maharaj Nakorn Chiangmai Hospital; November 2009 to November 2010; GERD; NERD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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 & Collaborators

• arpa pungrasamee: lead

Study Sites (1)

Maharaj Nakorn Chiangmai Hospital

Chiang Mai, Thailand

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Non-Erosive Reflux Disease

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: March 22, 2012
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 22, 2012

Record last verified: 2012-03

Locations

TH (1)