Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02685150
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Weifeng Wang, MD, Chinese PLA General Hospital

Tracking Information
First Submitted Date  ICMJE January 19, 2016
First Posted Date  ICMJE February 18, 2016
Last Update Posted Date July 19, 2018
Study Start Date  ICMJE January 2016
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02685150 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endoscopic Tri-Modal Imaging to Distinguish Functional Dyspepsia From Reflux Disease
Official Title  ICMJE The Role of Endoscopic Tri-Modal Imaging in Distinguishing Functional Dyspepsia From Reflux Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Gastroesophageal Reflux Disease
  • Dyspepsia
  • Bile Reflux
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Endoscopic Tri-Modal Imaging
    • Drug: Omeprazole
    • Other: Analysis of gastric juice
  • 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.
    Interventions:
    • Device: Endoscopic Tri-Modal Imaging
    • Drug: Omeprazole
    • Other: Analysis of gastric juice
  • 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.
    Interventions:
    • Device: Endoscopic Tri-Modal Imaging
    • Other: Analysis of gastric juice
  • 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.
    Interventions:
    • Device: Endoscopic Tri-Modal Imaging
    • Other: Analysis of gastric juice
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2018)
157
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2016)
200
Actual Study Completion Date  ICMJE June 2018
Actual Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02685150
Other Study ID Numbers  ICMJE S2015-086-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data are available from the W Wang, MD.
Responsible Party Weifeng Wang, MD, Chinese PLA General Hospital
Study Sponsor  ICMJE Chinese PLA General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Guoquan Ren, Ph.D. Chinese PLA General Hospital
PRS Account Chinese PLA General Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP