Diagnostic Value of Linked Color Imaging for Minimal Change Esophagitis in Nonerosive Reflux Esophagitis and GERD
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|ClinicalTrials.gov Identifier: NCT03068572|
Recruitment Status : Unknown
Verified September 2017 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was: Recruiting
First Posted : March 3, 2017
Last Update Posted : September 19, 2017
|Condition or disease|
|Gastroesophageal Reflux Disease Minimal Change Disease Non-Reflux Esophagitis|
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Official Title:||A Study on the Diagnosis of Minimal Change Esophagitis in Nonerosive Reflux Esophagitis and Gastroesophageal Reflux Disease Using Linked Color Imaging|
|Actual Study Start Date :||January 15, 2017|
|Estimated Primary Completion Date :||October 30, 2017|
|Estimated Study Completion Date :||December 30, 2017|
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.
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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068572
|Contact: Pei Deng, Ph.M.||+email@example.com|
|Contact: Min Min, Ph.D.||+firstname.lastname@example.org|
|Department of gastroenterology,Affiliated Hospital to Academy of Military Medical Sciences||Recruiting|
|Beijing, Beijing, China, 100071|
|Contact: Yan Liu +86-010-66947473 email@example.com|
|Principal Investigator: Min Min, M.D.|
|Principal Investigator:||Yan Liu, Ph.D.||Affiliate Hospital to Academy of Military Medical Sciences|