Narrow-band Imaging, Autofluorescence Imaging and Gastroesophageal Reflux Disease

Study Results

Results available

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Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-12-31

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).

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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

Conditions

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Gastroesophageal Reflux Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastroesophageal reflux disease (GERD)

symptom questionaire

Intervention Type OTHER

GerdQ questionaire

pH monitoring

Intervention Type PROCEDURE

24-hour pH monitoring

Tri-modal imaging endoscopy

Intervention Type PROCEDURE

To investigate WLI,NBI and AFI

rabeprazole

Intervention Type DRUG

10mg, bid, p.o.

Interventions

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symptom questionaire

GerdQ questionaire

Intervention Type OTHER

pH monitoring

24-hour pH monitoring

Intervention Type PROCEDURE

Tri-modal imaging endoscopy

To investigate WLI,NBI and AFI

Intervention Type PROCEDURE

rabeprazole

10mg, bid, p.o.

Intervention Type DRUG

Other Intervention Names

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GERD symptom questionaire Device was from Sierra Company Device was from Olympus Company PPI therapy

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes