Gastroesophageal Reflux DiseaseNCT03068572
Diagnostic Value of Linked Color Imaging for Minimal Change Esophagitis in Nonerosive Reflux Esophagitis and GERD
An observational study of Gastroesophageal Reflux Disease and Minimal Change Disease, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease, Minimal Change Disease, Non-Reflux Esophagitis
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2017to 30 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive adult patients undergoing an outpatient endoscopy
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences
Beijing, Beijing Municipality, 100071
Yan Liu, +86-010-66947473, 13911798288@163.com
Min Min, M.D.
About this study
Official title: 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.
Read the 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.
- Keywords
- minimal change esophageal reflux disease diagnosis, Linked Color imaging, non-erosive reflux disease
- Medical subject headings
- Gastroesophageal Reflux, Nephrosis, Lipoid, Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (1)
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
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start15 Jan 2017
- Primary completion30 Oct 2017 (estimated)
- Study completion30 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Liu, Ph.D., Principal investigator, Affiliate Hospital to Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068572
- Sponsor's protocol ID
- 307LCI-MCE
- Status last verified
- Sep 2017
- First submitted
- 22 Feb 2017
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 17681166Wang 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.
PubMed 25628366Lei 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.
PubMed 22156539Deng 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.
PubMed 30302374
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Diagnosis of Minimal Change Esophagitis in Nonerosive Reflux Esophagitis and Gastroesophageal Reflux Disease Using Linked Color Imaging
- ClinicalTrials.gov ID
- NCT03068572
- Acronym / sponsor ID
- 307LCI-MCE
- Keywords
- minimal change esophageal reflux disease diagnosis, Linked Color imaging, non-erosive reflux disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 30 Oct 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients undergoing an outpatient endoscopy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
observation minimal change esophagitis
Time frame: 5 months
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.
1 secondary outcome
Improvement observation agreement of Los Angeles classification system for GERD using LCI by comparing with that under white endoscopy
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Results publication: PubMed 17681166Sharma 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.
- Results publication: PubMed 25628366Wang 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.
- Results publication: PubMed 22156539Lei 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.
- Derived from this study: PubMed 30302374Deng 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Liu, Ph.D. principal investigator
Affiliate Hospital to Academy of Military Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease and Minimal Change Disease, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei Deng, Ph.M. (+86-010-66947473, dengpei1983@21cn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
observation minimal change esophagitis (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068572, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.