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

Primary Purpose

Gastroesophageal Reflux Disease, Dyspepsia, Bile Reflux

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Endoscopic Tri-Modal Imaging
Omeprazole
Analysis of gastric juice
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroesophageal Reflux Disease focused on measuring Endoscopic Tri-Modal Imaging, Gastric juice, Functional dyspepsia, Acid reflux disease, Bile reflux

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Functional dyspepsia

Acid reflux disease

Bile reflux disease

Health volunteers

Arm 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.

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.

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 19, 2016
Last Updated
July 17, 2018
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02685150
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Dyspepsia, Bile Reflux
Keywords
Endoscopic Tri-Modal Imaging, Gastric juice, Functional dyspepsia, Acid reflux disease, Bile reflux

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional dyspepsia
Arm Type
Experimental
Arm 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.
Arm Title
Acid reflux disease
Arm Type
Experimental
Arm 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.
Arm Title
Bile reflux disease
Arm Type
Experimental
Arm 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.
Arm Title
Health volunteers
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Endoscopic Tri-Modal Imaging
Intervention Description
Endoscope that combines white light imaging (WLI) with autofluorescence imaging (AFI) and narrow band imaging (NBI).
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
proton-pump inhibitor (PPI)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Analysis of gastric juice
Other Intervention Name(s)
Routine,biochemical, microbiological analysis
Intervention Description
Analysis of gastric juice including routine, biochemical and microbiological analysis.
Primary Outcome Measure Information:
Title
Numbers of participants with abnormal endoscopic findings and positive Omeprazole tests
Description
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.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoquan Ren, Ph.D.
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are available from the W Wang, MD.
Citations:
PubMed Identifier
23644963
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.
Results Reference
background
PubMed Identifier
25587615
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.
Results Reference
result

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

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