Working... Menu

Narrow-band Imaging, Autofluorescence Imaging and Gastroesophageal 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. Identifier: NCT01504971
Recruitment Status : Unknown
Verified August 2015 by Yunsheng Yang, Chinese PLA General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 6, 2012
Results First Posted : September 2, 2015
Last Update Posted : September 2, 2015
Information provided by (Responsible Party):
Yunsheng Yang, Chinese PLA General Hospital

Brief Summary:
Aim of this study is to compare the efficacy of narrow band imaging (NBI) and autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the diagnosis of gastroesophageal reflux disease (GERD).

Condition or disease Intervention/treatment
Gastroesophageal Reflux Disease Other: symptom questionaire Procedure: pH monitoring Procedure: Tri-modal imaging endoscopy Drug: rabeprazole

Detailed Description:

GERD is a common condition that develops when the reflux of gastric and/or duodenal contents causes troublesome symptoms with or without mucosal damage or complications. Despite the high prevalence of GERD in the general population, up to 60% of patients with reflux symptoms is insufficiently characterized as having normal endoscopic finding based on standard WLI endoscopy: non-erosive reflux diseases (NERD).

NBI is an optical-digital imaging technology that uses two specific narrow-banded shot wavelength lights (400-430 nm and 525-555 nm) instead of broad band white light. The NBI contrasts surface structure and vascular architecture of the superficial mucosa and facilitates evaluation of indistinct mucosal morphology. AFI produces real-time computed images of endoscopically detected autofluorescence emitted from endogenous fluorophores in the digestive tract (collagen, nicotinamide, adenine dinucleotide, flavin, and porphyrins) caused by light excitation. The AFI can identify lesions due to differences in tissue fluorescence properties that are not detectable by standard WLI. Hence, our hypothesis is that new endoscopic imaging i.e. NBI and AFI would help to identify subtle mucosal change which indicates the diagnosis of GERD

Layout table for study information
Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Value of Narrow-band Imaging, Autofluorescence Imaging & White-light Imaging on Gastroesophageal Reflux Disease
Study Start Date : January 2011
Actual Primary Completion Date : June 2012
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Gastroesophageal reflux disease (GERD) Other: symptom questionaire
GerdQ questionaire
Other Name: GERD symptom questionaire

Procedure: pH monitoring
24-hour pH monitoring
Other Name: Device was from Sierra Company

Procedure: Tri-modal imaging endoscopy
To investigate WLI,NBI and AFI
Other Name: Device was from Olympus Company

Drug: rabeprazole
10mg, bid, p.o.
Other Name: PPI therapy

Primary Outcome Measures :
  1. Diagnostic Ability of Each Endoscopic Finding for GERD Symptom. [ Time Frame: 1 month ]
    Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month

Secondary Outcome Measures :
  1. Association of Each Endoscopic Finding With Symptom Score [ Time Frame: 1 month ]
    Symptom score is assessed by a self-reported questionnaire

  2. Association of Each Endoscopic Finding With pH Monitoring Result [ Time Frame: 1 month ]
  3. Association of Each Endoscopic Finding With Treatment Effect of PPI [ Time Frame: 2 month ]
    Treatment effect of PPI is assessed by changes of symptom score

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients presented with reflux symptoms in outpatient clinic of a general hospital.
  1. Inclusion criteria

    • GERD symptom: heartburn or regurgitation (either one) at least 2 days a week
    • Presence of symptom for longer than 1 month before screening
    • Provision of written informed consent
  2. Exclusion criteria:

    • Any known esophageal disease or disorder, 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 identifier (NCT number): NCT01504971

Layout table for location information
China, Beijing
Outpatient Department Building
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Layout table for investigator information
Study Chair: Shuzhang Li, MD Chinese PLA General Hospital

Publications of Results:
Layout table for additonal information
Responsible Party: Yunsheng Yang, Professor, Department of Gastroenterology and Hepatology, Chinese PLA General Hospital Identifier: NCT01504971     History of Changes
Other Study ID Numbers: 20111013-001
First Posted: January 6, 2012    Key Record Dates
Results First Posted: September 2, 2015
Last Update Posted: September 2, 2015
Last Verified: August 2015

Keywords provided by Yunsheng Yang, Chinese PLA General Hospital:
Gastroesophageal Reflux;
Esophageal pH monitoring;
Narrow band imaging;
Autofluorescence imaging;
White light imaging;

Additional relevant MeSH terms:
Layout table for MeSH terms
Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action