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

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)

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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