Endoscopic Tri-Modal Imaging to Distinguish Functional Dyspepsia From Reflux Disease

C

Chinese PLA General Hospital (301 Hospital)

Status

Completed

Conditions

Dyspepsia
Gastroesophageal Reflux Disease
Bile Reflux

Treatments

Other: Analysis of gastric juice
Drug: Omeprazole
Device: Endoscopic Tri-Modal Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT02685150
S2015-086-02

Details and patient eligibility

About

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).

Full 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.

Enrollment

157 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

157 participants in 4 patient groups

Functional dyspepsia
Experimental group
Description:
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.
Treatment:
Device: Endoscopic Tri-Modal Imaging
Drug: Omeprazole
Other: Analysis of gastric juice
Acid reflux disease
Experimental group
Description:
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.
Treatment:
Device: Endoscopic Tri-Modal Imaging
Drug: Omeprazole
Other: Analysis of gastric juice
Bile reflux disease
Experimental group
Description:
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.
Treatment:
Device: Endoscopic Tri-Modal Imaging
Other: Analysis of gastric juice
Health volunteers
Experimental group
Description:
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.
Treatment:
Device: Endoscopic Tri-Modal Imaging
Other: Analysis of gastric juice

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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