The Efficacy of i-Scan for Detecting Reflux Esophagitis

Sponsor

Konkuk University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01381991

Collaborator

(none)

500

Enrollment

Location

Arm

Duration (Months)

45.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease Reflux Esophagitis	Device: i-scan	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Diagnostic

Official Title:

A Prospective Randomized Controlled Trial of the Efficacy of i-Scan for Detecting Reflux Esophagitis

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Pentax EPKi processor and EG-2890i endoscopy

Arm

Intervention/Treatment

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 Names:

Pentax EPKi processor and EG-2890i endoscopy

Outcome Measures

Primary Outcome Measures

To compare reflux esophagitis detection rate [from 2 to 3months after completeion of patients' enrollement]
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 [from 3 to 4 months after completeion of patients' enrollement]
using videoclip (for endoscopic finding of GE junction) of WL-EGD vs. i-scan-EGD from 60 randomly selected enrolled patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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