Diagnostic Value of Linked Color Imaging for Minimal Change Esophagitis in Nonerosive Reflux Esophagitis and GERD

A Study on the Diagnosis of Minimal Change Esophagitis in Nonerosive Reflux Esophagitis and Gastroesophageal Reflux Disease Using Linked Color Imaging

Linked color imaging(LCI),a new system for endoscopy modality,creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of magnifying blue laser imaging(BLI) technology.LCI makes red areas appear redder and white areas appear whiter.Thus,it is easier to recognize a slight difference in color of the mucosa.This is a study to assess the effectiveness of LCI for diagnosing esophageal minimal endoscopic lesions and Los Angeles classification system when compared to conventional white-light endoscopy (WLI).Gastroesophageal reflux disease(GERD) is a common disease that be defined as a condition which develops when the reflux of stomach contents cause troublesome symptoms and/or complications.Esophageal injury was classified according to the Los Angeles classification system,Non-erosive reflux disease(NERD) is defined by the presence of troublesome reflux-associated symptoms and the absence of mucosal breaks at endoscopy,which includes minimal change oesophagitis and no endoscopic abnormalities.LCI improved the visualization of the squamocolumnar junction (SCJ) by enhancing the contrast,mucosa minimal changes could be seen more easily and clearly with LCI than with standard white-light endoscopy.By comparing White-light endoscopy and LCI,it will show if there is any comparable advantage to using one or the other for lesion detection.

Study Overview

• Status: Unknown
• Conditions: Gastroesophageal Reflux Disease; Minimal Change Disease; Non-Reflux Esophagitis

Detailed Description

This is a prospective study comparing the use of linked color imaging(LCI) versus standard white light for the detection of minimal change esophageal.Gastroesophageal reflux disease(GERD) is a common disease that be defined as a condition which develops when the reflux of stomach contents cause troublesome symptoms and/or complications.At present,more than half the patients with GERD symptoms were diagnosed as having nonerosive reflux disease(NERD).However,by careful analysis,the majority of NERD patients did not have completely normal endoscopic finding but were found to have subtle distal esophageal mucosal changes.Forty-eight patients with suspected minimal change esophageal reflux disease(positive GerdQ but normal conventional endoscopy)and forty asymptomatic control were recruited.The new LCI(GF-L590WR) was performed.The criteria for positive liquid crystal thermography (LCT) were:a)triangular indentation,b)punctuate erythema.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100071
      • Recruiting
      • Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive adult patients undergoing an outpatient endoscopy

Description

Inclusion Criteria:

• age more than 18 year old
• ability to provide written informed consent and undergoing an upper endoscopy
• no PPI therapy in previous 2 weeks and no esophageal tumor or stenosis or history of esophageal surgery
• Patients with more than 3 reflux episodes/week and absence of mucosal breaks at conventional endoscopy，The PPI test was positive

Exclusion Criteria:

• unable to provide informed consent
• erosive esophagitis or diagnosis of erosive esophagitis within the recent 6 months
• presence of columnar lined epithelium
• evidence of cancer or mass lesion in the esophagus, gastric lesions (ulcer, polyp, cancer)
• previous gastrointestinal surgery
• esophageal strictures
• chronic use of medications known to affect esophageal motility
• presence of systemic diseases that might interfere with esophageal motility
• use of proton pump inhibitors(PPI) or histamine2-receptor antagonists in the last 4 weeks

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
NERD group; 45 GERD patients without obviously abnormality were examined by conventional white-light endoscopy and then followed by Linked Color imaging(LCI) to evaluate minimal change esophagitis and observation agreement of Los Angeles classification system GERD patients with the absence of mucosal breaks at conventional endoscopy,and those patients was given standard or double dose of oral proton pump inhibitor (PPI) for 2 weeks to determine the efficacy of anti-secretory therapy (the so-called PPI test).The response to PPI treatment comprised the NERD group.
Control group; 45 control patients were examined by white-light endoscopy and then followed by Linked Color imaging(LCI) to evaluate minimal change esophagitis and observation agreement of Los Angeles classification system,those subjects who had undergone endoscopy solely for the purpose of a health check-up at the same time of the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
observation minimal change esophagitis	conducted to assess the effectiveness of LCI for diagnosing esophageal MCE when compared to conventional white-light endoscopy (WLI).Meanwhile， interobserver and intraobserver variation in the use of LCI system between endoscopists with different levels of experience.	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement observation agreement of Los Angeles classification system for GERD using LCI by comparing with that under white endoscopy	It is anticipated that the use of Linked Color Imaging(LCI) will significantly improve the observation agreement of Los Angeles Classification when detected as opposed to White-light endoscopy	5 months

Collaborators and Investigators

• Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
• Investigators: Principal Investigator: Yan Liu, Ph.D., Affiliate Hospital to Academy of Military Medical Sciences

Publications and helpful links

General Publications

• Sharma P, Wani S, Bansal A, Hall S, Puli S, Mathur S, Rastogi A. A feasibility trial of narrow band imaging endoscopy in patients with gastroesophageal reflux disease. Gastroenterology. 2007 Aug;133(2):454-64; quiz 674. doi: 10.1053/j.gastro.2007.06.006. Epub 2007 Jun 8.
• Wang WH, Tsai KY. Narrow-band imaging of laryngeal images and endoscopically proven reflux esophagitis. Otolaryngol Head Neck Surg. 2015 May;152(5):874-80. doi: 10.1177/0194599814568285. Epub 2015 Jan 27.
• Lei WY, Liu TT, Yi CH, Chen CL. Disease characteristics in non-erosive reflux disease with and without endoscopically minimal change esophagitis: are they different? Digestion. 2012;85(1):27-32. doi: 10.1159/000334715. Epub 2011 Dec 13.
• Deng P, Min M, Dong T, Bi Y, Tang A, Liu Y. Linked color imaging improves detection of minimal change esophagitis in non-erosive reflux esophagitis patients. Endosc Int Open. 2018 Oct;6(10):E1177-E1183. doi: 10.1055/a-0602-3997. Epub 2018 Oct 8.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2017
• Primary Completion (Anticipated): October 30, 2017
• Study Completion (Anticipated): December 30, 2017

Study Registration Dates

• First Submitted: February 22, 2017
• First Submitted That Met QC Criteria: February 26, 2017
• First Posted (Actual): March 3, 2017

Study Record Updates

• Last Update Posted (Actual): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: non-erosive reflux disease; minimal change esophageal reflux disease diagnosis; Linked Color imaging
• Additional Relevant MeSH Terms: Digestive System Diseases; Kidney Diseases; Urologic Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Peptic Ulcer; Duodenal Diseases; Nephrosis; Gastroesophageal Reflux; Esophagitis, Peptic; Esophagitis; Nephrosis, Lipoid
• Other Study ID Numbers: 307LCI-MCE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No