Clinical trial NCT01742377: Minimal Change Esophagitis by i-Scan Endoscopy in Dyspeptic Patients
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
Dyspepsia
Ambulatory 24-hour Esophageal pH Monitoring
Minimal change erosions
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with dyspepsia from clinics , primary care clinics ,community.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with one or more of the following symptoms namely epigastric pain or discomfort, postprandial fullness and early satiety with or without symptoms suggesting GERD
* Patients able to give informed consent

Exclusion Criteria:

* Patients with significant weight loss.
* Patients with hematemesis, melena ,dysphagia, intractable vomiting , palpable abdominal mass.
* Patients with history of documented peptic ulcer , gastric surgery , gastric cancer.
* Patients with symptoms compatible with irritable bowel syndrome, hepatobiliary tract disease.
* Patients with severe concomitant medical conditions, pregnant woman or continuous usage of steroids or NSIADS in the preceding 1 month before entry to the study.

Primary outcomes:
measure: Evidence of minimal change erosions detected by i-scan endoscopy.
timeFrame: within day of endoscopy
Secondary outcomes:
measure: Number of patients with dyspepsia are diagnosed gastroesophageal reflux disease by Gerd Q.
timeFrame: within the first 7 days after endoscopy
measure: Number of patients with dyspepsia are confirmed with GERD
timeFrame: within the first 7 days after endoscopy
measure: Total acid exposure in normal volunteers
timeFrame: 1 day
Other outcomes:
Locations:
city: Hatyai
country: Thailand
facility: NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
state: Songkla
Study officials:
affiliation: NKC Institue of Gastroenterology and Hepatology,Prince of Songkla University
name: Dr.Nisa Netinatsunton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Netinatsunton N, Sottisuporn J, Attasaranya S, Witeerungrot T, Chamroonkul N, Jongboonyanuparp T, Geater A, Ovartlarnporn B. i-Scan detection of minimal change esophagitis in dyspeptic patients with or without Gastroesophageal Reflux disease. BMC Gastroenterol. 2016 Jan 14;16:4. doi: 10.1186/s12876-016-0417-4.