Novel Imaging Techniques in Barrett's Esophagus

Summary

Primary Aim: In patients with endoscopically suspected BE, compared to standard endoscopy, novel techniques (NBI and AFI) with target biopsies will

* Detect more patients with intestinal metaplasia
* Detect more areas of high grade dysplasia
* Require fewer biopsies and a shorter time for procedure completion

Secondary Aim:

* Compare the yield of high-grade dysplasia(HGD)using NBI/AFI versus standard endoscopy with biopsy.
* Compare the number of biopsies and procedure times for NBI/AFI versus standard endoscopy with biopsy.
* Compare the inter-observer variability in classifying different mucosal and vascular patterns observed by NBI/AFI using kappa statistics.

Conditions

• Barrett Esophagus
• Gastroesophageal Reflux

Interventions

OTHER

NBI-AFI imaging

Narrow Band Imaging- Patients will be evaluated with a standard magnification endoscope (Olympus GIF Q240Z, 115x or GIF-H180 or equivalent) using a NBI light source.Target biopsies with standard biopsy forceps will be obtained from the different visualized patterns in separate jars. Autofluorescence Imaging- Patients will be evaluated using a prototype autofluorescence endoscope (Olympus, Tokyo, Japan; excitation 395-475 nm, fluorescence detection 490-625 nm, red reflectance 600-620 nm and green reflectance 540-560 nm).In this system, normal squamous and non-dysplastic BE appears green while the dysplastic areas appear magenta/purplish. Targeted biopsies will be obtained from the areas with abnormal fluorescence.

OTHER

Standard Endoscopy

Standard Endoscopy- Patients will undergo EGD with biopsies using a standard diagnostic video endoscope (Olympus, GIF 140 or 160) using the Seattle protocol - 4 quadrant biopsies using standard biopsy forceps every 2 cms; stored in separate jars.

Sponsors & Collaborators

• Kansas City Veteran Affairs Medical Center

  collaborator FED

• Medical University of South Carolina

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Midwest Biomedical Research Foundation

  lead OTHER

Principal Investigators

• Prateek Sharma, MD · Veterans Affairs Medical Center, Kansas City, MO; University of Kansas School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-10-31

Primary Completion

2009-05-31

Completion

2009-05-31

Countries

• United States
• Netherlands

Study Locations