Detection of Minimal Change Esophagitis Using Confocal Laser Endomicroscopy

Terminated

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Device: Confocal endomicroscope (Pentax Model EC3870K)

• Registration Number: NCT00954070
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

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).

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.

Study Timeline

• Study First Submitted: 2009-07-08
• Study Start: 2009-08
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-26
• Last Update Posted: 2012-12-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case (subjects with NERD)	Confocal endomicroscope (Pentax Model EC3870K)	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.
Control	Confocal endomicroscope (Pentax Model EC3870K)	Healthy individuals aged between 21 and 65 years who are asymptomatic for GERD and other digestive diseases

Primary Outcome Measures

Name	Time	Method
Specific microscopic changes in the esophageal mucosa as seen under the confocal endomicroscope	After 4 weeks phamacological washout period

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore