Minimal Change Esophagitis by i-Scan Endoscopy in Dyspeptic Patients

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Procedure: Patients with GerdQ positive; Procedure: Normal volunteers; Procedure: Patients with GerdQ negative

• Registration Number: NCT01742377
• Lead Sponsor: Prince of Songkla University

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2012-10-28
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-05
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-01
• Last Update Submitted: 2015-04-11
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with GerdQ positive	Patients with GerdQ positive	Gerd Q positive was defined as score equal or more than eight.
Normal volunteers	Normal volunteers	Normal volunteers was defined as population without dyspeptic symptom.
Patients with GerdQ negative	Patients with GerdQ negative	Gerd Q neegative was defined as score less than eight.

Primary Outcome Measures

Name	Time	Method
Evidence of minimal change erosions detected by i-scan endoscopy.	within day of endoscopy	Minimal change lesions (MCL) included punctate erythema (PE), minute erosion (ME) and triangular lesion with elongated pit (TLE).

Secondary Outcome Measures

Name	Time	Method
Number of patients with dyspepsia are diagnosed gastroesophageal reflux disease by Gerd Q.	within the first 7 days after endoscopy	The GerdQ score equal or more than 8 is a positive score for GERD
Number of patients with dyspepsia are confirmed with GERD	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 .
Total acid exposure in normal volunteers	1 day	The mean value of total acid exposure of 40 normal volunteer.

Trial Locations

Locations (1)

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University; 🇹🇭 Hatyai, Songkla, Thailand