Narrow-band Imaging, Autofluorescence Imaging and Gastroesophageal Reflux Disease

Study Overview
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Brief Summary
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Aim of this study is to compare the efficacy of narrow band imaging (NBI) and autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the diagnosis of gastroesophageal reflux disease (GERD).

Detailed Description
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GERD is a common condition that develops when the reflux of gastric and/or duodenal contents causes troublesome symptoms with or without mucosal damage or complications. Despite the high prevalence of GERD in the general population, up to 60% of patients with reflux symptoms is insufficiently characterized as having normal endoscopic finding based on standard WLI endoscopy: non-erosive reflux diseases (NERD). NBI is an optical-digital imaging technology that uses two specific narrow-banded shot wavelength lights (400-430 nm and 525-555 nm) instead of broad band white light. The NBI contrasts surface structure and vascular architecture of the superficial mucosa and facilitates evaluation of indistinct mucosal morphology. AFI produces real-time computed images of endoscopically detected autofluorescence emitted from endogenous fluorophores in the digestive tract (collagen, nicotinamide, adenine dinucleotide, flavin, and porphyrins) caused by light excitation. The AFI can identify lesions due to differences in tissue fluorescence properties that are not detectable by standard WLI. Hence, our hypothesis is that new endoscopic imaging i.e. NBI and AFI would help to identify subtle mucosal change which indicates the diagnosis of GERD

Official Title
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Diagnostic Value of Narrow-band Imaging, Autofluorescence Imaging & White-light Imaging on Gastroesophageal Reflux Disease

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Other: symptom questionaire
* Procedure: pH monitoring
* Procedure: Tri-modal imaging endoscopy
* Drug: rabeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion criteria GERD symptom: heartburn or regurgitation (either one) at least 2 days a week Presence of symptom for longer than 1 month before screening Provision of written informed consent Exclusion criteria: Any known esophageal disease or disorder, other than reflux esophagitis Active or healing gastroduodenal ulcer (except scars) History of esophageal or gastric surgery. Clinically significant heart, lung, liver or kidney disease Allergy to proton-pump inhibitor Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastroesophageal reflux disease (GERD)<br> | Other: symptom questionaire<br>* GerdQ questionaire<br>* Other names: GERD symptom questionaire;Procedure: pH monitoring<br>* 24-hour pH monitoring<br>* Other names: Device was from Sierra Company;Procedure: Tri-modal imaging endoscopy<br>* To investigate WLI,NBI and AFI<br>* Other names: Device was from Olympus Company;Drug: rabeprazole<br>* 10mg, bid, p.o.<br>* Other names: PPI therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Ability of Each Endoscopic Finding for GERD Symptom. | Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of Each Endoscopic Finding With Symptom Score | Symptom score is assessed by a self-reported questionnaire | 1 month | 
| Association of Each Endoscopic Finding With pH Monitoring Result |  | 1 month | 
| Association of Each Endoscopic Finding With Treatment Effect of PPI | Treatment effect of PPI is assessed by changes of symptom score | 2 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal Reflux;, Endoscopy;, Esophageal pH monitoring;, Narrow band imaging;, Autofluorescence imaging;, White light imaging;