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

NCT02685150 | Completed DMC

• 1 other identifier: S2015-086-02
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastroesophageal Reflux Disease; Dyspepsia; Bile Reflux

Keywords

Endoscopic Tri-Modal Imaging; Gastric juice; Functional dyspepsia; Acid reflux disease; Bile reflux

Outcome Measures

Primary Outcomes (1)

• Numbers of participants with abnormal endoscopic findings and positive Omeprazole tests

  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.

  one month

Study Arms (4)

Functional dyspepsia

EXPERIMENTAL

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.

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

Acid reflux disease

EXPERIMENTAL

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.

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

Bile reflux disease

EXPERIMENTAL

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.

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

Health volunteers

EXPERIMENTAL

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.

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

Interventions

Endoscopic Tri-Modal Imaging DEVICE

Endoscope that combines white light imaging (WLI) with autofluorescence imaging (AFI) and narrow band imaging (NBI).

Acid reflux disease; Bile reflux disease; Functional dyspepsia; Health volunteers

Omeprazole DRUG

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.

Also known as: proton-pump inhibitor (PPI)

Acid reflux disease; Functional dyspepsia

Analysis of gastric juice OTHER

Analysis of gastric juice including routine, biochemical and microbiological analysis.

Also known as: Routine,biochemical, microbiological analysis

Acid reflux disease; Bile reflux disease; Functional dyspepsia; Health volunteers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• symptoms suggestive of GERD or dyspepsia.
• Presence of symptom for longer than 6 month
• Provision of written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

Location

Related Publications (2)

• 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.

  PMID: 23644963 BACKGROUND

• 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.

  PMID: 25587615 RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux; Dyspepsia; Bile Reflux

Interventions

Omeprazole; Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Biliary Tract Diseases; Duodenogastric Reflux; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Guoquan Ren, Ph.D.

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: February 18, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)