Detection of Minimal Change Esophagitis Using Confocal Laser Endomicroscopy

This study has been terminated.
(Difficulty in recruiting subjects for study)
Sponsor:
Information provided by (Responsible Party):
Medicine, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00954070
First received: July 8, 2009
Last updated: December 26, 2012
Last verified: December 2012
  Purpose

This is an observational, prospective and pilot study to determine through confocal endomicroscopy diagnostic microscopic features detectable at the gastroesophageal junction of patients with non-erosive gastroesophageal reflux disease.

The hypothesis is that minimal mucosal changes occur in non-erosive gastroesophageal reflux disease. Although these minimal changes are not always visible on white-light endoscopy, it is detectable using high-resolution confocal endomicroscopy and these confocal features are diagnostic of non-erosive reflux disease (NERD).


Condition Intervention
Gastroesophageal Reflux Disease
Device: Confocal endomicroscope (Pentax Model EC3870K)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Detection of Minimal Change Esophagitis Using Confocal Laser Endomicroscopy

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Specific microscopic changes in the esophageal mucosa as seen under the confocal endomicroscope [ Time Frame: After 4 weeks phamacological washout period ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: August 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Case (subjects with NERD)
The investigators cases are subjects with confirmed NERD and include male or female patients aged between 21 and 65 years, who present with typical clinical manifestations of gastroesophageal reflux and have no esophageal mucosal breaks upon conventional white-light endoscopy examination but show evidence of pathologic gastroesophageal reflux on 24-hr pH monitoring.
Device: Confocal endomicroscope (Pentax Model EC3870K)
The intervention is an endoscopy procedure using a novel type of endoscope with a powerful confocal microscope attached to its tip. The endoscope (Pentax Model EC3870K) provides both white-light and confocal microscopic imaging.
Other Name: Pentax Model EC3870K, Pentax Corp, Tokyo, Japan
Control
Healthy individuals aged between 21 and 65 years who are asymptomatic for GERD and other digestive diseases
Device: Confocal endomicroscope (Pentax Model EC3870K)
The intervention is an endoscopy procedure using a novel type of endoscope with a powerful confocal microscope attached to its tip. The endoscope (Pentax Model EC3870K) provides both white-light and confocal microscopic imaging.
Other Name: Pentax Model EC3870K, Pentax Corp, Tokyo, Japan

Detailed Description:

In Asia, up to 70% of patients with typical gastroesophageal reflux symptoms could have non-erosive reflux disease (NERD), in which case, no detectable mucosal break may be observed on conventional white-light endoscopy. However, minimal change lesions are often visible upon high-resolution endoscopy and on microscopic examination of biopsied specimens. The most commonly seen microscopic features are dilated intercellular space, infiltration of inflammatory cells into squamous epithelia, hyperplasia of the epithelial basal cell and elongation of the papillae. So far, the most consistent histologic change found in NERD has been the dilated intercellular space in esophageal epithelium. But until now, determinations of intercellular space dilatations could only be done ex-vivo on biopsy specimens using transmission electron microscopy or light microscopy. With the advent of high-resolution confocal laser endomicroscopy, in-vivo determination of intercellular space dilatations and other diagnostic microscopic features could be a reality. This study is aimed at exploring such a clinical possibility and feasibility, with the intention of comparing the microscopic findings based on confocal endomicroscopy with that of symptoms, and esophageal pH.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Hosipital patients with typical clinical manifestations of gastroesophageal reflux disease but no endoscopy evidence of esophagitis.

Criteria

Inclusion Criteria:

  • Cases:

    • male or female patients aged between 21 and 65 years with typical clinical manifestations of gastroesophageal reflux but endoscopy-negative for esophageal mucosal breaks
    • by typical clinical manifestations of gastroesophageal reflux, we refer to the occurrence of heartburn and/or regurgitation more than twice a week, with a minimum duration of 8 consecutive weeks, and with symptoms severe enough to affect daily activities
  • Controls:

    • healthy male or female aged between 21 and 65 years who are asymptomatic for GERD and other digestive diseases

Exclusion Criteria:

  • Endoscopic confirmed erosive esophagitis
  • Complications such as Barrett's esophagus, gastric and/or duodenal peptic ulcer, stenosis
  • Esophageal, gastric or duodenal cancer or other malignancy
  • History of esophagus, stomach, or duodenum surgery
  • Conditions that preclude safe biopsies (coagulopathy, haemophilia, esophageal varices, and patients on warfarin and antiplatelets)
  • Scleroderma, diabetes mellitus, autonomic or peripheral neuropathy, myopathy or any underlying disease or medication that might affect the lower esophageal sphincter pressure or increase the acid clearance time
  • A history of bronchial asthma, or known allergy to fluorescein
  • Pregnant or breast-feeding (for females)
  • Below 21 or above 65 years of age
  • Severe co-morbidities (e.g., such as end-stage renal failure, congestive cardiac failure, liver cirrhosis, severe arthritis requiring long term non-steroidal anti-inflammatory drug therapy)
  • Unable or unwilling to give informed consent
  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: NCT00954070

Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Khek Yu Ho, MD National University Hospital, Singapore
  More Information

Publications:
Responsible Party: Medicine, Professor & Senior Consultant Gastroenterologist, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00954070     History of Changes
Other Study ID Numbers: E/09/026
Study First Received: July 8, 2009
Last Updated: December 26, 2012
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
gastroesophageal reflux disease

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 July 22, 2014