Bile Reflux, Dyspepsia, Gastroesophageal Reflux Disease
Conditions
Keywords
Endoscopic Tri-Modal Imaging, Gastric juice, Functional dyspepsia, Acid reflux disease, Bile reflux
Brief summary
Endoscopic Tri-Modal Imaging which combines Narrow-band Imaging(NBI), Autofluorescence Imaging (AFI) and White-light Imaging (WLI) could be used to identify the indistinct changes in the gut caused by reflux disease,either acid reflux or bile reflux, which make it possible to differentiate reflux disease from functional dyspepsia (FD).
Detailed description
Functional dyspepsia (FD) and acid/bile reflux disease are common. These diseases share similar clinical manifestations. Individuals with functional dyspepsia (FD) often present upper abdominal pain or discomfort, bloating, early satiety, loss of appetite, and no organic factors underlie it. Individuals suffering from acid/bile reflux disease often complain heartburn, upper abdominal burning or discomfort. What is more, there are always no specific changes on traditional endoscopy that can be used to differentiate these diseases (except erosive esophagitis). Though proton-pump inhibitor (PPI) test is frequently applied to confirm the diagnosis of acid reflux disease, but certain amounts of individuals with gastroesophageal reflux disease (GERD) do not show favorable response to PPI test. In order to make a distinction of these diseases, esophageal pH-metry is needed, however it is not always available in most clinics. Recent data showed that new endoscopic technology such as Endoscopic Tri-Modal Imaging could demonstrate indistinct lesions caused by GERD which are not detectable by standard endoscopy, subsequently improve endoscopic diagnosis of these diseases. In addition, simultaneous analysis of gastric juice can help to determine whether bile reflux is present or not. As it is known, pathologic refluxes underlie not functional dyspepsia but acid/bile reflux disease. Hence, it is hypothesized that Endoscopic Tri-Modal Imaging in combination with simultaneous analysis of gastric juice could be used to differentiate functional dyspepsia from acid/bile reflux disease.
Interventions
DEVICEEndoscopic Tri-Modal Imaging
Endoscope that combines white light imaging (WLI) with autofluorescence imaging (AFI) and narrow band imaging (NBI).
DRUGOmeprazole
Omeprazole is one kind of proton-pump inhibitors. All participants undergo standard proton-pump inhibitor (PPI) tests for two weeks with Omeprazole, 20mg twice a day.
OTHERAnalysis of gastric juice
Analysis of gastric juice including routine, biochemical and microbiological analysis.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* symptoms suggestive of GERD or dyspepsia. * Presence of symptom for longer than 6 month * Provision of written informed consent
Exclusion criteria
* Any known upper GI disease, 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 |
|---|---|---|
| Numbers of participants with abnormal endoscopic findings and positive Omeprazole tests | one month | Numbers of participants with abnormal endoscopic findings are used to calculate the diagnostic Value of Endoscopic Tri-Modal Imaging in Distinguishing Functional Dyspepsia and Reflux Disease, including specificity, sensitivity and accuracy. |
Countries
China
Outcome results
None listed