This trial is active, not recruiting.

Condition gastroesophageal reflux disease
Treatments symptom questionaire, ph monitoring, tri-modal imaging endoscopy, rabeprazole
Sponsor Chinese PLA General Hospital
Start date January 2011
End date June 2012
Trial size 100 participants
Trial identifier NCT01504971, 20111013-001


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
symptom questionaire GERD symptom questionaire
GerdQ questionaire
ph monitoring Device was from Sierra Company
24-hour pH monitoring
tri-modal imaging endoscopy Device was from Olympus Company
To investigate WLI,NBI and AFI
rabeprazole PPI therapy
10mg, bid, p.o.

Primary Outcomes

Diagnostic ability of each endoscopic finding for GERD symptom.
time frame: 1 month

Secondary Outcomes

Association of each endoscopic finding with symptom score
time frame: 1 month
Association of each endoscopic finding with pH monitoring result
time frame: 1 month
Association of each endoscopic finding with treatment effect of PPI
time frame: 2 month

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

1. 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 2. 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

Additional Information

Official title Diagnostic Value of Narrow-band Imaging, Autofluorescence Imaging & White-light Imaging on Gastroesophageal Reflux Disease
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Chinese PLA General Hospital.