Narrow-band Imaging, Autofluorescence Imaging and Gastroesophageal Reflux Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yunsheng Yang, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01504971
First received: January 4, 2012
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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 Intervention
Gastroesophageal Reflux Disease
Other: symptom questionaire
Procedure: pH monitoring
Procedure: Tri-modal imaging endoscopy
Drug: rabeprazole

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic Value of Narrow-band Imaging, Autofluorescence Imaging & White-light Imaging on Gastroesophageal Reflux Disease

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • Diagnostic ability of each endoscopic finding for GERD symptom. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month


Secondary Outcome Measures:
  • Association of each endoscopic finding with symptom score [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Symptom score is assessed by a self-reported questionnaire

  • Association of each endoscopic finding with pH monitoring result [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Association of each endoscopic finding with treatment effect of PPI [ Time Frame: 2 month ] [ Designated as safety issue: No ]
    Treatment effect of PPI is assessed by changes of symptom score


Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients presented with reflux symptoms in outpatient clinic of a general hospital.

Criteria
  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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504971

Locations
China, Beijing
Outpatient Department Building
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
Study Chair: Shuzhang Li, MD Chinese PLA General Hospital
  More Information

Publications:
Responsible Party: Yunsheng Yang, Professor, Department of Gastroenterology and Hepatology, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01504971     History of Changes
Other Study ID Numbers: 20111013-001
Study First Received: January 4, 2012
Last Updated: March 1, 2013
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 20, 2014