NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110, Thailand
NCT Number: NCT01742377
The purpose of this study to assess efficacy of SE endoscopy in the detection of MCE in dyspeptic patients with or without GERD diagnosed by GerdQ or by endoscopy + PHM and in normal volunteers.
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Notify Me18 year and older
All sexes
Observational
Hat Yai, Changwat Songkhla, 90110, Thailand
Background: The association of minimal change esophagitis (MCE) with gastroesophageal reflux (GERD) is controversy. High resolution endoscopy may improve the detection of minimal change lesion (MCL). i- Scan endoscopy (SE) provides high resolution images with modulation of images for a specific purpose.
Methods. All dyspeptic patients with or without GERD symptoms scheduled for endoscopy were recruited from February 2010 till July 2014. All completed the validated Thai version of GerdQ then underwent endoscopy. Forty normal volunteers were recruited for endoscopy and PHM test. 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), minute erosion (ME) and triangular lesion with elongated pit (EP) by three endoscopists. The agreement of > 2 endoscopists was accepted as a final result. All had PHM within 1 week after the endoscopy. GERD was diagnosed by LA grade A-D esophagitis and/or PHM with acid exposure time > the upper limit of volunteer and/or positive symptom index and/or positive Symptom Association Probability. MCE was diagnosed when PE, ME or EP or the combination of these were present.
The 40 normal volunteers were recruited for performing pH monitoring. The PHM data of 40 volunteers were analyzed to set the upper normal limit of total acid exposure time in our population. The mean + 2SD of total acid exposure time of volunteers was 1.9%.
Definition. GerdQ. The Thai version of GerdQ was translated from the English version. The contents of the GerdQ were tested by back translation from Thai to English by 5 personnel who are fluent in English and all showed the consistent contents. The reliability of the GerdQ was validated in 22 volunteers completing the questionnaire twice with 3 hours in between and showed no significant difference of the mean score (5.14+ 2.34 vs 6.23+ 1.57, p=0.07) and the number of subjects with GERD diagnosed by the GerdQ (2 vs 5, Fisher's extact test, p=0.21) .
GERD is diagnosed when total acid exposure time is more than 2% or positive symptom index (SI) or positive symptom association probability ( SAP ) or endoscopy revealed LA erosive esophagitis > grade A.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients done GerdQ questionnaire, then undergone EGD. The distal esophagus was examined by HD and followed by SE with a preset TE mode for esophagus ( TE-e mode ). All patients had pH monitoring study within 1 week after the endoscopy.
Patients done GerdQ questionnaire, then undergone EGD. The distal esophagus was examined by HD and followed by SE with a preset TE mode for esophagus ( TE-e mode ). All patients had pH monitoring study within 1 week after the endoscopy.
Normal volunteers undergone EGD.The distal esophagus was examined by HD and followed by SE with a preset TE mode for esophagus ( TE-e mode ).
Time frame: within day of endoscopy
Minimal change lesions (MCL) included punctate erythema (PE), minute erosion (ME) and triangular lesion with elongated pit (TLE).
Time frame: within the first 7 days after endoscopy
The GerdQ score equal or more than 8 is a positive score for GERD
Time frame: within the first 7 days after endoscopy
GERD is diagnosed when total acid exposure time is more than 2% or positive symptom index (SI) or positive symptom association probability ( SAP ) or endoscopy revealed LA erosive esophagitis > grade A .
Time frame: 1 day
The mean value of total acid exposure of 40 normal volunteer.
Prince of Songkla University
Other
i-Scan Endoscopy in the Detection of Minimal Change Esophagitis in Dyspeptic Patients With or Without Gastroesophageal Reflux Disease by Gerd Q Questionnaire and by 24 Hour pH Monitoring.
Acronym: MCE
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