The Efficacy of i-Scan for Detecting Reflux Esophagitis

This study has been completed.
Sponsor:
Information provided by:
Konkuk University Hospital
ClinicalTrials.gov Identifier:
NCT01381991
First received: May 17, 2011
Last updated: June 24, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Gastroesophageal Reflux Disease
Reflux Esophagitis
Device: i-scan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: A Prospective Randomized Controlled Trial of the Efficacy of i-Scan for Detecting Reflux Esophagitis

Resource links provided by NLM:


Further study details as provided by Konkuk University Hospital:

Primary Outcome Measures:
  • To compare reflux esophagitis detection rate [ Time Frame: from 2 to 3months after completeion of patients' enrollement ] [ Designated as safety issue: No ]
    using videoclip (for endoscopic finding of GE junction) of WL-EGD vs. i-scan-EGD of all enrolled patients


Secondary Outcome Measures:
  • To evaluate the interobserver agreement using modified LA classification [ Time Frame: from 3 to 4 months after completeion of patients' enrollement ] [ Designated as safety issue: No ]
    using videoclip (for endoscopic finding of GE junction) of WL-EGD vs. i-scan-EGD from 60 randomly selected enrolled patients


Estimated Enrollment: 500
Study Start Date: July 2010
Study Completion Date: June 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: i-scan-EGD
Examination of GE junction using conventional WL as well as i-scan mode
Device: i-scan
For all the study procedures, Pentax EPKi processor and high-resolution adult video endoscopes (EG-2890i; Pentax, Japan) with push button switch from WL to i-scan were used. I-scan consist of three modes of image enhancement including SE, CE, ant TE. For SE and CE, switching among three enhancement levels (2+,3+,4+) is possible. Although SE and CE modes can allow detailed observation of subtle mucosal irregularities, noise increases as enhancement becomes more intense. In addition, TE is possible to switch p (pit pattern), v (vessel), b (Barrett), e (esophagus), g (stomach) and c (colo-rectum) mode.
Other Name: Pentax EPKi processor and EG-2890i endoscopy

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01381991

Locations
Korea, Republic of
Healthcare Center, Digestive Disease Center, Konkuk University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Konkuk University Hospital
Investigators
Principal Investigator: Sung Noh Hong, M.D. Konkuk University Medical Center,Konkuk University School of Medicine
  More Information

No publications provided

Responsible Party: Sung Noh Hong, M.D., Department of Internal Medicine, Konkuk University School of Medicine
ClinicalTrials.gov Identifier: NCT01381991     History of Changes
Other Study ID Numbers: KUMCHSN03
Study First Received: May 17, 2011
Last Updated: June 24, 2011
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Konkuk University Hospital:
Gastroesophageal Reflux Disease
Reflux esophagitis
i-scan

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Gastroesophageal Reflux
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on April 15, 2014