Minimal Injuries From Esophagus Detected by Optical Enhancement System™ Associated to Optical Magnification HD Scopes

Summary

White light endoscopy remains the gold standard technique to evaluate gastrointestinal tract. Gastroesophageal Reflux Disease (GERD) is defined as presence of reflux symptoms (heartburn and regurgitation) associated or not with lesions in esophageal mucosa. Based on findings at videoendoscopy GERD patients can have a complicated reflux disease (erosive esophagitis) or not and be considered as a non erosive reflux disease (NERD). 60% of GERD patients have normal endoscopy (NERD) and requires further studies to achieve a definitive diagnosis. Based on this fact is that the study will be focus on NERD patients.

Recently an image-enhanced endoscopic technology using a pre-processor band-limited light called Optical Enhancement system (OE system™), was developed (Pentax Medical). This new technology combines digital signal processing with optical filters that limit the spectral characteristics of the illumination light. The new innovated optical filters achieve higher overall transmittance by connecting the peaks of the hemoglobin absorption spectrum (415 nm, 540 nm and 570 nm) creating a continuous wavelength spectrum. There are two modes with different OE filters (Mode 1 and Mode 2). Mode 1 is designed to improve visualization of microvessels with a sufficient amount of light, and Mode 2 is designed to improve contrast of white-light observation by bringing the color tone of the overall image closer to that of natural color.

In addition, new scopes has been developed which combines high definition images with optical magnification called Magniview™. These scopes increase the image up to 136 times with a better quality of image than standard scopes without optical zoom. Sharma et al. evaluated esophageal changes in NERD patients using a similar pre-processor filter called Narrow Band Imaging (NBI). They found that a significantly higher proportion of patients with NERD had an increased number, dilation and tortuosity of the microscopic intrapapillary capillary loops (IPCLs), and were considered the best predictors for diagnosing NERD. They used optical chromoendoscopy technology (NBI) associated to magnification scopes (Olympus GIF Q240Z, 115x), but they did not evaluated if the contribution with this technology to the observations found in GERD patients were as a result of the NBI or the magnification scopes. The investigators opinion is that chromoendoscopy is useful but is the magnification what makes up the difference.

Conditions

• Non Erosive Reflux Disease
• GERD

Interventions

DEVICE

Optical Enhancement

A endoscopic visualization of the mucosa using the pre-processor filter called Optical enhancement (Pentax Video Processor EPK-i7010; HOYA Co. Tokyo, Japan)

DEVICE

Optical Enhancement with optical magnification

A endoscopic visualization of the mucosa using the pre-processor filter called Optical enhancement associated with an optical magnification using the scope called magniview (PENTAX Medical EG-2990Zi)

DEVICE

Optical magnification without Optical enhancement

A endoscopic visualization of the mucosa using optical magnification without the use of the pre-processor filter called Optical enhancement

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas

  lead OTHER

Principal Investigators

• Carlos A Robles-Medranda, MD · Ecuadorian Institute of Digestive Diseases

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-09-30

Primary Completion

2016-01-31

Completion

2016-01-31

Countries

• Ecuador

Study Locations