Narrow-band Imaging, Autofluorescence Imaging and Gastroesophageal Reflux Disease

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Other: symptom questionaire; Procedure: pH monitoring; Procedure: Tri-modal imaging endoscopy; Drug: rabeprazole

• Registration Number: NCT01504971
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-06
• Primary Completion: 2012-06
• Status Verified: 2015-08
• Results First Submitted: 2015-08-04
• Results First Submitted QC: 2015-08-04
• Last Update Submitted: 2015-08-04
• Results First Posted: 2015-09-02
• Last Update Posted: 2015-09-02
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastroesophageal reflux disease (GERD)	symptom questionaire	-
Gastroesophageal reflux disease (GERD)	pH monitoring	-
Gastroesophageal reflux disease (GERD)	Tri-modal imaging endoscopy	-
Gastroesophageal reflux disease (GERD)	rabeprazole	-

Primary Outcome Measures

Name	Time	Method
Diagnostic Ability of Each Endoscopic Finding for GERD Symptom.	1 month	Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Outpatient Department Building; 🇨🇳 Beijing, Beijing, China