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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Nisa Netinatsunton, Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01742377
First received: October 28, 2012
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study to assess 1)the efficacy of high definition endoscopy (HD) and i-Scan endoscopy (SE) in detecting esophageal minimal change erosions (MCL) in dyspeptic patients with or without GERD 2) the efficacy of GERD Q compared with 24 hour pH monitoring(PHM)in GERD diagnosis.


Condition Intervention
Gastroesophageal Reflux Disease
 Procedure: Endoscopy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Minimal Change Esophagitis (MCE) by i-Scan Endoscopy in Dyspeptic Patients With or Without Gastroesophageal Reflux Disease(GERD) by Gerd Q Questionnaire and 24-hour-pH Monitoring (PHM)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • Evidence of minimal change erosions detected by HD and SE [ Time Frame: within day of endoscopy ] [ Designated as safety issue: No ]
    To determine efficacy of high definition white light (HD) and i-scan (SE )endoscopy in detecting esophageal minimal change lesions (MCL) included punctate erythema (PE), blurred vessels (BV), minute erosion (ME) and triangular lesion with elongated pit (TLE) in dyspeptic patients with or without GERD diagnosed by GerdQ and by 24 hour pH monitoring.


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 ]
    To determine efficacy of Gerd Q questionnaire in diagnosis of gastroesophageal reflux disease in patients with dyspepsia compared with 24 hour pH monitoring.


Enrollment: 200
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with dyspepsia
All patients completed Thai version GerdQ then underwent endoscopy. All had PHM within 1 weeks after the endoscopy.
 Procedure: Endoscopy
All patients undergone endoscopy. 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), blurred vessels (BV), minute erosion (ME) and triangular lesion with elongated pit (TLE)) by three endoscopists. The agreement of > 2 endoscopists was accepted as a final result.
Other Name: EGD

Detailed Description:

The GERD Q is a validated tool for GERD diagnosis and accepted in the western countries where the prevalnce of GERD is higher than in Asia.Minimal change lesions (MCL) is one of endoscopic finding in non erosive reflux disease ,but the association of MCL with GERD is controversy. i- Scan is a newly developed image-enhanced endoscopy that provides higher resolution images and modulated images to improve the details of gastrointestinal epithelium and vascularity may improve the detection of the esophageal MCL in GERD.

  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
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: December 3, 2012
Health Authority: Thailand: Ethical Committee

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

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

ClinicalTrials.gov processed this record on May 23, 2013