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Trial record 19 of 40 for:    Recruiting, Not yet recruiting, Available Studies | "Dyspepsia"

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

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ClinicalTrials.gov Identifier: NCT02685150
Recruitment Status : Recruiting
First Posted : February 18, 2016
Last Update Posted : February 22, 2016
Sponsor:
Information provided by (Responsible Party):
Weifeng Wang, MD, Chinese PLA General Hospital

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).

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Dyspepsia Bile Reflux Device: Endoscopic Tri-Modal Imaging Drug: Omeprazole Other: Analysis of gastric juice Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of Endoscopic Tri-Modal Imaging in Distinguishing Functional Dyspepsia From Reflux Disease
Study Start Date : January 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Omeprazole

Arm Intervention/treatment
Experimental: Functional dyspepsia
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
Endoscope that combines white light imaging (WLI) with autofluorescence imaging (AFI) and narrow band imaging (NBI).

Drug: Omeprazole
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.
Other Name: proton-pump inhibitor (PPI)

Other: Analysis of gastric juice
Analysis of gastric juice including routine, biochemical and microbiological analysis.
Other Name: Routine,biochemical, microbiological analysis

Experimental: Acid reflux disease
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
Endoscope that combines white light imaging (WLI) with autofluorescence imaging (AFI) and narrow band imaging (NBI).

Drug: Omeprazole
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.
Other Name: proton-pump inhibitor (PPI)

Other: Analysis of gastric juice
Analysis of gastric juice including routine, biochemical and microbiological analysis.
Other Name: Routine,biochemical, microbiological analysis

Experimental: Bile reflux disease
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
Endoscope that combines white light imaging (WLI) with autofluorescence imaging (AFI) and narrow band imaging (NBI).

Other: Analysis of gastric juice
Analysis of gastric juice including routine, biochemical and microbiological analysis.
Other Name: Routine,biochemical, microbiological analysis

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

Other: Analysis of gastric juice
Analysis of gastric juice including routine, biochemical and microbiological analysis.
Other Name: Routine,biochemical, microbiological analysis




Primary Outcome Measures :
  1. Numbers of participants with abnormal endoscopic findings and positive Omeprazole tests [ Time Frame: one month ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685150


Contacts
Contact: Weifeng Wang, MD. 0086-68154653 wangwf301@hotmail.com

Locations
China
Chinese PLA General Hospital Recruiting
Beijing, China, 100853
Contact: Weifeng Wang, MD    0086-68154653    wangwf301@hotmail.com   
Principal Investigator: Weifeng Wang, MD         
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Chair: Guoquan Ren, Ph.D. Chinese PLA General Hospital

Publications of Results:
Other Publications:
Responsible Party: Weifeng Wang, MD, Associate Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02685150     History of Changes
Other Study ID Numbers: S2015-086-02
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: February 22, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data are available from the W Wang, MD.

Keywords provided by Weifeng Wang, MD, Chinese PLA General Hospital:
Endoscopic Tri-Modal Imaging
Gastric juice
Functional dyspepsia
Acid reflux disease
Bile reflux

Additional relevant MeSH terms:
Dyspepsia
Gastroesophageal Reflux
Bile Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Biliary Tract Diseases
Duodenogastric Reflux
Stomach Diseases
Omeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action