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The Efficacy of i-Scan for Detecting Reflux Esophagitis

Primary Purpose

Gastroesophageal Reflux Disease, Reflux Esophagitis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
i-scan
Sponsored by
Konkuk University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal Reflux Disease, Reflux esophagitis, i-scan

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Healthcare Center, Digestive Disease Center, Konkuk University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

i-scan-EGD

Arm Description

Examination of GE junction using conventional WL as well as i-scan mode

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 17, 2011
Last Updated
June 24, 2011
Sponsor
Konkuk University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01381991
Brief Title
The Efficacy of i-Scan for Detecting Reflux Esophagitis
Official Title
A Prospective Randomized Controlled Trial of the Efficacy of i-Scan for Detecting Reflux Esophagitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Konkuk University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 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. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Reflux Esophagitis
Keywords
Gastroesophageal Reflux Disease, Reflux esophagitis, i-scan

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
i-scan-EGD
Arm Type
Experimental
Arm Description
Examination of GE junction using conventional WL as well as i-scan mode
Intervention Type
Device
Intervention Name(s)
i-scan
Other Intervention Name(s)
Pentax EPKi processor and EG-2890i endoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare reflux esophagitis detection rate
Description
using videoclip (for endoscopic finding of GE junction) of WL-EGD vs. i-scan-EGD of all enrolled patients
Time Frame
from 2 to 3months after completeion of patients' enrollement
Secondary Outcome Measure Information:
Title
To evaluate the interobserver agreement using modified LA classification
Description
using videoclip (for endoscopic finding of GE junction) of WL-EGD vs. i-scan-EGD from 60 randomly selected enrolled patients
Time Frame
from 3 to 4 months after completeion of patients' enrollement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Noh Hong, M.D.
Organizational Affiliation
Konkuk University Medical Center,Konkuk University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthcare Center, Digestive Disease Center, Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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The Efficacy of i-Scan for Detecting Reflux Esophagitis

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