Gastroesophageal Reflux Disease
Conditions
Keywords
Gastroesophageal Reflux;, Endoscopy;, Esophageal pH monitoring;, Narrow band imaging;, Autofluorescence imaging;, White light imaging;
Brief summary
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
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
Interventions
OTHERsymptom questionaire
GerdQ questionaire
PROCEDUREpH monitoring
24-hour pH monitoring
PROCEDURETri-modal imaging endoscopy
To investigate WLI,NBI and AFI
DRUGrabeprazole
10mg, bid, p.o.
Sponsors
Chinese PLA General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Ability of Each Endoscopic Finding for GERD Symptom. | 1 month | Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association of Each Endoscopic Finding With Symptom Score | 1 month | Symptom score is assessed by a self-reported questionnaire |
| Association of Each Endoscopic Finding With pH Monitoring Result | 1 month | — |
| Association of Each Endoscopic Finding With Treatment Effect of PPI | 2 month | Treatment effect of PPI is assessed by changes of symptom score |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gastroesophageal Reflux Disease (GERD) symptom questionaire: GerdQ questionaire
pH monitoring: 24-hour pH monitoring
Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI
rabeprazole: 10mg, bid, p.o. | 95 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 13 |
Baseline characteristics
| Characteristic | Gastroesophageal Reflux Disease (GERD) |
|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 12 |
| Region of Enrollment China | 95 participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants | Diagnostic Ability of Each Endoscopic Finding for GERD Symptom. | 21 percentage of participants |
| Participants Same to arm1 | Diagnostic Ability of Each Endoscopic Finding for GERD Symptom. | 77 percentage of participants |
| Participants Same to Previous Arm | Diagnostic Ability of Each Endoscopic Finding for GERD Symptom. | 60 percentage of participants |
Secondary
Association of Each Endoscopic Finding With pH Monitoring Result
Time frame: 1 month
Secondary
Association of Each Endoscopic Finding With Symptom Score
Symptom score is assessed by a self-reported questionnaire
Time frame: 1 month
Secondary
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