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

September 18, 2017 updated by: Affiliated Hospital to Academy of Military Medical Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: 5 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Affiliated Hospital to Academy of Military Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yan Liu, Ph.D., Affiliate Hospital to Academy of Military Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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