Detection of Minimal Change Esophagitis by I-scan
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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) |
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 |
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.
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.
Contacts and Locations 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:
|
Esophageal Diseases Gastroesophageal Reflux Gastrointestinal Diseases |
Digestive System Diseases Esophageal Motility Disorders Deglutition Disorders |
ClinicalTrials.gov processed this record on May 16, 2013