Clinical trial NCT02685150: Endoscopic Tri-Modal Imaging to Distinguish Functional Dyspepsia From Reflux Disease
Official title: The Role of Endoscopic Tri-Modal Imaging in Distinguishing Functional Dyspepsia From Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Dyspepsia
Bile Reflux
Keywords: Endoscopic Tri-Modal Imaging
Gastric juice
Functional dyspepsia
Acid reflux disease
Bile reflux
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numbers of participants with abnormal endoscopic findings and positive Omeprazole tests
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Guoquan Ren, Ph.D.
role: STUDY_CHAIR
References:
citation: Talley NJ. Functional (non-ulcer) dyspepsia and gastroesophageal reflux disease: one not two diseases? Am J Gastroenterol. 2013 May;108(5):775-7. doi: 10.1038/ajg.2013.102.
citation: Wang W, Uedo N, Yang Y, Peng L, Bai D, Lu Z, Fan K, Wang J, Wang X, Zhao Y, Yu Z. Autofluorescence imaging endoscopy for predicting acid reflux in patients with gastroesophageal reflux disease. J Gastroenterol Hepatol. 2014;29(7):1442-8. doi: 10.1111/jgh.12566. No abstract available.