Minimal Change Esophagitis by i-Scan Endoscopy in Dyspeptic Patients (MCE)
The purpose of this study to assess 1)the efficacy of high definition endoscopy (HD) and i-Scan endoscopy (SE) in detecting esophageal minimal change erosions (MCL) in dyspeptic patients with or without GERD 2) the efficacy of GERD Q compared with 24 hour pH monitoring(PHM)in GERD diagnosis.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Minimal Change Esophagitis (MCE) by i-Scan Endoscopy in Dyspeptic Patients With or Without Gastroesophageal Reflux Disease(GERD) by Gerd Q Questionnaire and 24-hour-pH Monitoring (PHM)|
- Evidence of minimal change erosions detected by HD and SE [ Time Frame: within day of endoscopy ] [ Designated as safety issue: No ]To determine efficacy of high definition white light (HD) and i-scan (SE )endoscopy in detecting esophageal minimal change lesions (MCL) included punctate erythema (PE), blurred vessels (BV), minute erosion (ME) and triangular lesion with elongated pit (TLE) in dyspeptic patients with or without GERD diagnosed by GerdQ and by 24 hour pH monitoring.
- Number of patients with dyspepsia are diagnosed gastroesophageal reflux disease by Gerd Q. [ Time Frame: within the first 7 days after endoscopy ] [ Designated as safety issue: No ]To determine efficacy of Gerd Q questionnaire in diagnosis of gastroesophageal reflux disease in patients with dyspepsia compared with 24 hour pH monitoring.
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Patients with dyspepsia
All patients completed Thai version GerdQ then underwent endoscopy. All had PHM within 1 weeks after the endoscopy.
All patients undergone endoscopy. The esophagus was examined by HD and SE with the TE-e mode sequentially. The captured images were independently evaluated for MCL (punctate erythema (PE), blurred vessels (BV), minute erosion (ME) and triangular lesion with elongated pit (TLE)) by three endoscopists. The agreement of > 2 endoscopists was accepted as a final result.
Other Name: EGD
The GERD Q is a validated tool for GERD diagnosis and accepted in the western countries where the prevalnce of GERD is higher than in Asia.Minimal change lesions (MCL) is one of endoscopic finding in non erosive reflux disease ,but the association of MCL with GERD is controversy. i- Scan is a newly developed image-enhanced endoscopy that provides higher resolution images and modulated images to improve the details of gastrointestinal epithelium and vascularity may improve the detection of the esophageal MCL in GERD.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742377
|NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University|
|Hatyai, Songkla, Thailand, 90110|
|Principal Investigator:||Dr.Nisa Netinatsunton, MD||NKC Institue of Gastroenterology and Hepatology,Prince of Songkla University|