Detection of Minimal Change Esophagitis Using Confocal Laser Endomicroscopy

National University Health System (NUHS)

Status: Terminated

Conditions: Gastroesophageal Reflux Disease

Treatments: Device: Confocal endomicroscope (Pentax Model EC3870K)

Study type: Observational

Funder types: Other

Identifiers

NCT00954070

E/09/026

Details and patient eligibility

About

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).

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

6 participants in 2 patient groups

Case (subjects with NERD)

Description:

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.

Treatment:

Device: Confocal endomicroscope (Pentax Model EC3870K)

Control

Description:

Healthy individuals aged between 21 and 65 years who are asymptomatic for GERD and other digestive diseases

Treatment:

Device: Confocal endomicroscope (Pentax Model EC3870K)