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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nisa Netinatsunton, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01742377
First received: October 28, 2012
Last updated: April 11, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention
Gastroesophageal Reflux Disease
Procedure: Patients with GerdQ positive
Procedure: Patients with GerdQ negative
Procedure: Normal volunteers

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • Evidence of minimal change erosions detected by i-scan endoscopy. [ Time Frame: within day of endoscopy ] [ Designated as safety issue: No ]
    Minimal change lesions (MCL) included punctate erythema (PE), minute erosion (ME) and triangular lesion with elongated pit (TLE).


Secondary Outcome Measures:
  • Number of patients with dyspepsia are diagnosed gastroesophageal reflux disease by Gerd Q. [ Time Frame: within the first 7 days after endoscopy ] [ Designated as safety issue: No ]
    The GerdQ score equal or more than 8 is a positive score for GERD

  • Number of patients with dyspepsia are confirmed with GERD [ Time Frame: within the first 7 days after endoscopy ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The mean value of total acid exposure of 40 normal volunteer.


Enrollment: 174
Study Start Date: February 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 ).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742377

Locations
Thailand
NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
Hatyai, Songkla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Dr.Nisa Netinatsunton, MD NKC Institue of Gastroenterology and Hepatology,Prince of Songkla University
  More Information

No publications provided

Responsible Party: Nisa Netinatsunton, NKC Institute of Gastrornterology and Hepatology, Prince of Songkla University
ClinicalTrials.gov Identifier: NCT01742377     History of Changes
Other Study ID Numbers: EC 53-017-21-1-2
Study First Received: October 28, 2012
Last Updated: April 11, 2015
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
GERD
Dyspepsia
Ambulatory 24-hour Esophageal pH Monitoring
Minimal change erosions

Additional relevant MeSH terms:
Esophagitis
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 20, 2015