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

NCT03068572 | Unknown DMC

• 1 other identifier: 307LCI-MCE
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroesophageal Reflux Disease; Minimal Change Disease; Non-Reflux Esophagitis

Keywords

minimal change esophageal reflux disease diagnosis; Linked Color imaging; non-erosive reflux disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Improvement observation agreement of Los Angeles classification system for GERD using LCI by comparing with that under white endoscopy

  5 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive adult patients undergoing an outpatient endoscopy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences

Beijing, Beijing Municipality, 100071, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 17681166 RESULT

• 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.

  PMID: 25628366 RESULT

• 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.

  PMID: 22156539 RESULT

• 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.

  PMID: 30302374 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Nephrosis, Lipoid; Non-Erosive Reflux Disease

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Nephrosis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yan Liu, Ph.D.

  Affiliate Hospital to Academy of Military Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei Deng, Ph.M.

CONTACT

+86-010-66947473; dengpei1983@21cn.com

Min Min, Ph.D.

CONTACT

+86-010-66947473; minmin823@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 3, 2017
• Study Start: January 15, 2017
• Primary Completion: October 30, 2017
• Study Completion: December 30, 2017
• Last Updated: September 19, 2017

Record last verified: 2017-09

Locations

CN (1)