The Efficacy of i-Scan for Detecting Reflux Esophagitis

NCT01381991 | Completed

• 1 other identifier: KUMCHSN03
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

1. 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. 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.

Conditions

Gastroesophageal Reflux Disease; Reflux Esophagitis

Keywords

Gastroesophageal Reflux Disease; Reflux esophagitis; i-scan

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• To evaluate the interobserver agreement using modified LA classification

  from 3 to 4 months after completeion of patients' enrollement

Study Arms (1)

i-scan-EGD

EXPERIMENTAL

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

Device: i-scan

Interventions

i-scan DEVICE

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.

Also known as: Pentax EPKi processor and EG-2890i endoscopy

i-scan-EGD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18 to 80 years
• completed standard questionnaire including upper gastrointestinal symptoms
• underwent screening endoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Konkuk University Hospital: lead

Study Sites (1)

Healthcare Center, Digestive Disease Center, Konkuk University Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Esophagitis, Peptic

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Study Officials

• Sung Noh Hong, M.D.

  Konkuk University Medical Center,Konkuk University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 17, 2011
• First Posted: June 27, 2011
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: June 1, 2011
• Last Updated: June 27, 2011

Record last verified: 2011-06

Locations

KR (1)