An observational study in Gastroesophageal Reflux Disease, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-02.
Sponsored by Chinese PLA General Hospital · Observational
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).
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
1,066 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 95 is below the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presented with reflux symptoms in outpatient clinic of a general hospital.
GERD symptom: heartburn or regurgitation (either one) at least 2 days a week
Any known esophageal disease or disorder, other than reflux esophagitis
Other: symptom questionaire · Procedure: pH monitoring · Procedure: Tri-modal imaging endoscopy · Drug: rabeprazole
GerdQ questionaire
Also known as: GERD symptom questionaire
24-hour pH monitoring
Also known as: Device was from Sierra Company
To investigate WLI,NBI and AFI
Also known as: Device was from Olympus Company
10mg, bid, p.o.
Also known as: PPI therapy
Diagnostic Ability of Each Endoscopic Finding for GERD Symptom.
Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month
Time frame: 1 month
Association of Each Endoscopic Finding With Symptom Score
Symptom score is assessed by a self-reported questionnaire
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
Treatment effect of PPI is assessed by changes of symptom score
Time frame: 2 month
| Milestone | Gastroesophageal Reflux Disease (GERD) |
|---|---|
| Started | 95 |
| Completed | 82 |
| Not completed | 13 |
| Withdrew: Physician decision | 13 |
Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month
| percentage of participants | Participants | Participants Same to arm1 | Participants Same to Previous Arm |
|---|---|---|---|
| Diagnostic Ability of Each Endoscopic Finding for GERD Symptom. | 21 (9 to 32) | 77 (65 to 89) | 60 (45 to 74) |
Symptom score is assessed by a self-reported questionnaire
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Treatment effect of PPI is assessed by changes of symptom score
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants | — | — | — |
| Participants Same to arm1 | — | — | — |
| Participants Same to Previous Arm | — | — | — |
| Age, Continuous(years) | Gastroesophageal Reflux Disease (GERD) |
|---|---|
| Mean | 49 ± 12 |
| Sex: Female, Male(Participants) | Gastroesophageal Reflux Disease (GERD) |
|---|---|
| Female | 43 |
| Male | 52 |
| Region of Enrollment(participants) | Gastroesophageal Reflux Disease (GERD) |
|---|---|
| China | 95 |
This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Chinese PLA General Hospital