Status:
TERMINATED
Detection of Minimal Change Esophagitis Using Confocal Laser Endomicroscopy
Lead Sponsor:
National University Hospital, Singapore
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
21-65 years
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-eros...
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 wh...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00954070
Start Date
August 1 2009
End Date
April 1 2012
Last Update
December 28 2012
Active Locations (1)
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1
National University Hospital
Singapore, Singapore, 119074