Minimal Change Esophagitis by i-Scan Endoscopy in Dyspeptic Patients

Gastroesophageal Reflux Disease Clinical Trial

— MCE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01742377
• Other study ID #: EC 53-017-21-1-2
• Status: Completed
• Phase: N/A
• First received: October 28, 2012
• Last updated: April 11, 2015
• Start date: February 2010
• Est. completion date: July 2014

Study information

• Verified date: January 2015
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Esophagitis
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

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
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 undergone EGD.The distal esophagus was examined by HD and followed by SE with a preset TE mode for esophagus ( TE-e mode ).

Locations

Country	Name	City	State
Thailand	NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University	Hatyai	Songkla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Total acid exposure in normal volunteers	The mean value of total acid exposure of 40 normal volunteer.	1 day	No