Endoscopic Tri-Modal Imaging to Distinguish Functional Dyspepsia From Reflux Disease
- Conditions
- Gastroesophageal Reflux DiseaseDyspepsiaBile Reflux
- Interventions
- Registration Number
- NCT02685150
- Lead Sponsor
- Chinese PLA General Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 157
- symptoms suggestive of GERD or dyspepsia.
- Presence of symptom for longer than 6 month
- Provision of written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Functional dyspepsia Endoscopic Tri-Modal Imaging Participants are to undergo Endoscopic Tri-Modal Imaging, Omeprazole test and Analysis of gastric juice and those who fulfill with Rome III criteria for functional dyspepsia are to be classified into this group. Functional dyspepsia Omeprazole Participants are to undergo Endoscopic Tri-Modal Imaging, Omeprazole test and Analysis of gastric juice and those who fulfill with Rome III criteria for functional dyspepsia are to be classified into this group. Functional dyspepsia Analysis of gastric juice Participants are to undergo Endoscopic Tri-Modal Imaging, Omeprazole test and Analysis of gastric juice and those who fulfill with Rome III criteria for functional dyspepsia are to be classified into this group. Acid reflux disease Endoscopic Tri-Modal Imaging Participants are to undergo Endoscopic Tri-Modal Imaging, Omeprazole test and Analysis of gastric juice. Participants with acid reflux are to confirmed by Omeprazole test, one kind of proton-pump inhibitor (PPI) tests. Acid reflux disease Omeprazole Participants are to undergo Endoscopic Tri-Modal Imaging, Omeprazole test and Analysis of gastric juice. Participants with acid reflux are to confirmed by Omeprazole test, one kind of proton-pump inhibitor (PPI) tests. Acid reflux disease Analysis of gastric juice Participants are to undergo Endoscopic Tri-Modal Imaging, Omeprazole test and Analysis of gastric juice. Participants with acid reflux are to confirmed by Omeprazole test, one kind of proton-pump inhibitor (PPI) tests. Bile reflux disease Endoscopic Tri-Modal Imaging Participants are to undergo Endoscopic Tri-Modal Imaging and Analysis of gastric juice. Participants with bile reflux are to be confirmed by Analysis of gastric juice. Bile reflux disease Analysis of gastric juice Participants are to undergo Endoscopic Tri-Modal Imaging and Analysis of gastric juice. Participants with bile reflux are to be confirmed by Analysis of gastric juice. Health volunteers Endoscopic Tri-Modal Imaging Health volunteers for routine checkup. Participants are to undergo Endoscopic Tri-Modal Imaging as well as Analysis of gastric juice and those who show no abnormal findings are to be classified into this group. Health volunteers Analysis of gastric juice Health volunteers for routine checkup. Participants are to undergo Endoscopic Tri-Modal Imaging as well as Analysis of gastric juice and those who show no abnormal findings are to be classified into this group.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, China