Minimal Change Esophagitis by i-Scan Endoscopy in Dyspeptic Patients (MCE)

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.

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.

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Procedure: Patients with GerdQ positive; Procedure: Patients with GerdQ negative; Procedure: 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 Type: Observational
• Enrollment (Actual): 174

Contacts and Locations

Study Locations

• Thailand
  • Songkla
    • Hatyai, Songkla, Thailand, 90110
      • NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with dyspepsia from clinics , primary care clinics ,community.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with GerdQ positive; Gerd Q positive was defined as score equal or more than eight.	Procedure: Patients with GerdQ positive; 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 with GerdQ negative; Gerd Q neegative was defined as score less than eight.	Procedure: Patients with GerdQ negative; 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; Normal volunteers was defined as population without dyspeptic symptom.	Procedure: Normal volunteers; 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 ).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Prince of Songkla University
• Investigators: Principal Investigator: Dr.Nisa Netinatsunton, MD, NKC Institue of Gastroenterology and Hepatology,Prince of Songkla University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: October 28, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (ESTIMATE): December 5, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 11, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: GERD; Dyspepsia; Ambulatory 24-hour Esophageal pH Monitoring; Minimal change erosions
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Esophagitis
• Other Study ID Numbers: EC 53-017-21-1-2