Gastroesophageal Reflux Disease Clinical Trial
Official title:
A Prospective Randomized Controlled Trial of the Efficacy of i-Scan for Detecting Reflux Esophagitis
Verified date | June 2011 |
Source | Konkuk University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Ministry for Health and Welfare |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 500 |
Est. completion date | June 2011 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - aged 18 to 80 years - completed standard questionnaire including upper gastrointestinal symptoms - underwent screening endoscopy Exclusion Criteria: - a patients with history of gastrointestinal surgery such as gastrectomy, fundoplication, or distal esophagectomy - a patients were not able to record video clips during the period of examination of the gastro-esophageal junction |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Healthcare Center, Digestive Disease Center, Konkuk University Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Konkuk University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare reflux esophagitis detection rate | using videoclip (for endoscopic finding of GE junction) of WL-EGD vs. i-scan-EGD of all enrolled patients | from 2 to 3months after completeion of patients' enrollement | No |
Secondary | To evaluate the interobserver agreement using modified LA classification | using videoclip (for endoscopic finding of GE junction) of WL-EGD vs. i-scan-EGD from 60 randomly selected enrolled patients | from 3 to 4 months after completeion of patients' enrollement | No |
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