- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01560910
Detection of Minimal Change Esophagitis by I-scan
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Chiangmai, Thailand
- Maharaj Nakorn Chiangmai Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISSNEXI0018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-erosive Reflux Disease
-
Daewoong Pharmaceutical Co. LTD.RecruitingNon-erosive Reflux Disease | Non-Erosive Gastro-Esophageal Reflux Disease | Non-Erosive Esophageal Reflux DiseaseKorea, Republic of
-
Braintree LaboratoriesEnrolling by invitationA Study to Evaluate the Long-Term Safety of BLI5100 in Patients With Gastroesophageal Reflux DiseaseNon-erosive Reflux Disease | Erosive EsophagitisUnited States
-
Federal State Budgetary Scientific Institution...RecruitingGastroesophageal Reflux Disease | GERD | Non-erosive Reflux Disease | Erosive Esophagitis | Non-Erosive Gastro-Esophageal Reflux Disease | Gastroesophageal ErosionRussian Federation
-
Seoul National University Bundang HospitalCompletedErosive Reflux Disease | Non-erosive Reflux Disease | Functional HeartburnKorea, Republic of
-
TakedaTerminatedGastroesophageal Reflux Disease | Non-erosive Reflux DiseaseSwitzerland, Netherlands
-
Braintree LaboratoriesActive, not recruitingNon-erosive Reflux DiseaseUnited States
-
Midwest Biomedical Research FoundationKansas City Veteran Affairs Medical CenterCompletedNon-erosive Reflux DiseaseUnited States, United Kingdom
-
LCMC HealthTerminatedGastroesophageal Reflux | Non-erosive Reflux DiseaseUnited States
-
Yuhan CorporationCompletedNon-erosive Reflux DiseaseKorea, Republic of
-
Vanderbilt University Medical CenterCompletedGastroesophageal Reflux Disease (GERD) | Non-erosive Reflux Disease (NERD)United States