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

NCT ID: NCT03068572

Last Updated: 2017-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-15

Study Completion Date

2017-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastroesophageal Reflux Disease Minimal Change Disease Non-Reflux Esophagitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this 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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Affiliated Hospital to Academy of Military Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Liu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Affiliate Hospital to Academy of Military Medical Sciences

Locations

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

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Pei Deng, Ph.M.

Role: CONTACT

[email protected]
+86-010-66947473

Min Min, Ph.D.

Role: CONTACT

[email protected]
+86-010-66947473

Facility Contacts

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Yan Liu

Role: primary

[email protected]
+86-010-66947473

References

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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.

Reference Type RESULT
PMID: 17681166 (View on PubMed)

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.

Reference Type RESULT
PMID: 25628366 (View on PubMed)

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.

Reference Type RESULT
PMID: 22156539 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30302374 (View on PubMed)

Other Identifiers

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307LCI-MCE

Identifier Type: -

Identifier Source: org_study_id