Gastroesophageal Reflux Disease Clinical Trial
Official title:
A Prospective Randomized Controlled Trial of the Efficacy of i-Scan for Detecting Reflux Esophagitis
Endoscopy is a widely used modality for the diagnosis and classification of Gastroesophageal
reflux disease (GERD), and the extent of esophageal mucosal breaks on endoscopy can be
assessed. However, there were some limitation in diagnosis of GERD using endoscopy
1. More than half of patients with GERD reveal no visible abnormality on conventional
endoscopy, it is possible that minute mucosal changes are underestimated by
conventional endoscopy due to the limitation of visual ability
2. In addition of uncertainty in detecting mucosal breaks, uncertainty in describing
severity of mucosal injury can lead to inconsistency among interpreters. Interobserver
agreement regarding diagnosis and classification of GERD using endoscopy is
unsatisfactory to apply daily practice.
Thus, the development of a new method to define the intra-esophageal injury for use in daily
practice is a worthwhile endeavor and developed, such as narrow−band imaging (NBI), Fuji
Intelligent Chromoen−doscopy (FICE) and i-scan.
Among them, i-scan technology is the most recently developed image enhancing technology,
which consists of three modes of image enhancement, i.e. surface enhancement (SE), contrast
enhancement (CE), and tone enhancement (TE).
Thus, the investigators examined the hypothesis that i-scan can improve the detection rate
of reflux esophagitis and inter-observer agreement between endoscopists compared with
conventional white light (WL) endoscopic examination.
Gastroesophageal reflux disease (GERD) is a condition that develops when reflux of stomach
contents causes troublesome symptoms and/or complications. It is the most frequent problem
in upper gastrointestinal tract in outpatient clinic and contributes substantially to
morbidity and to costs. Endoscopy is a widely used modality for the diagnosis and
classification of GERD, and the extent of esophageal mucosal breaks on endoscopy can be
assessed. However, because more than half of patients with GERD reveal no visible
abnormality on conventional endoscopy, it is possible that minute mucosal changes are
underestimated by conventional endoscopy due to the limitation of visual ability.
In addition of uncertainty in detecting mucosal breaks, uncertainty in describing severity
of mucosal injury can lead to inconsistency among interpreters. Asian gastroenterologists
tend to diagnose endoscopically before they treat patients with symptoms suggestive of GERD
and use the modified Los Angeles (LA) classification system that includes minimal changes as
constituting a distinct grade of reflux esophagitis. In modified LA system, minimal change
esophagitis is characterized by the mucosa such as erythema and/or whitish turbidity.
However, because substantial overlap is noted between normal and minimal change, minimal
change and LA class A, and LA class A and B, interobserver agreement regarding diagnosis and
classification of reflux esophagitis is unsatisfactory to apply daily practice. Thus, the
development of a new method to define the intra-esophageal injury for use in daily practice
is a worthwhile endeavor.
Currently, new imaging technologies have applied in endoscopy to improve detecting and
differentiating the subtle mucosal changes using digital contrast method such as narrow−band
imaging (NBI), Fuji Intelligent Chromoen−doscopy (FICE) and i-scan. Among them, i-scan
technology is the most recently developed image enhancing technology, which consists of
three modes of image enhancement, i.e. surface enhancement (SE), contrast enhancement (CE),
and tone enhancement (TE). SE enhances light-dark contrast and CE adds blue color in
relatively dark areas digitally, by obtaining luminance intensity data for each pixel.
Applying SE and CE might allow detailed observation of subtle irregularities around the
surface and TE analyzes the individual RGB components of a normal image and recombines the
color frequencies of each component to enhance minute mucosal structures with subtle color
changes.
Thus, the investigators examined the hypothesis that i-scan can improve the detection rate
of reflux esophagitis and inter-observer agreement between endoscopists compared with
conventional white light (WL) endoscopic examination
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
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