Narrow-band Imaging, Autofluorescence Imaging and Gastroesophageal Reflux Disease

Diagnostic Value of Narrow-band Imaging, Autofluorescence Imaging & White-light Imaging on Gastroesophageal Reflux Disease

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).

Study Overview

• Status: Unknown
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Outpatient Department Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gastroesophageal reflux disease (GERD)	Other: symptom questionaire; GerdQ questionaire; Other Names: GERD symptom questionaire; Procedure: pH monitoring; 24-hour pH monitoring; Other Names: Device was from Sierra Company; Procedure: Tri-modal imaging endoscopy; To investigate WLI,NBI and AFI; Other Names: Device was from Olympus Company; Drug: rabeprazole; 10mg, bid, p.o.; Other Names: PPI therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic Ability of Each Endoscopic Finding for GERD Symptom.	Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of Each Endoscopic Finding With Symptom Score	Symptom score is assessed by a self-reported questionnaire	1 month
Association of Each Endoscopic Finding With pH Monitoring Result		1 month
Association of Each Endoscopic Finding With Treatment Effect of PPI	Treatment effect of PPI is assessed by changes of symptom score	2 month

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Study Chair: Shuzhang Li, MD, Chinese PLA General Hospital

Publications and helpful links

General Publications

• Fock KM, Teo EK, Ang TL, Tan JY, Law NM. The utility of narrow band imaging in improving the endoscopic diagnosis of gastroesophageal reflux disease. Clin Gastroenterol Hepatol. 2009 Jan;7(1):54-9. doi: 10.1016/j.cgh.2008.08.030. Epub 2008 Sep 3.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: January 4, 2012
• First Submitted That Met QC Criteria: January 4, 2012
• First Posted (Estimate): January 6, 2012

Study Record Updates

• Last Update Posted (Estimate): September 2, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: Gastroesophageal Reflux;; Endoscopy;; Esophageal pH monitoring;; Narrow band imaging;; Autofluorescence imaging;; White light imaging
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: 20111013-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No