Novel Imaging Techniques in Barrett's Esophagus

This study has been completed.
Sponsor:
Collaborators:
Kansas City Veteran Affairs Medical Center
Medical University of South Carolina
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
PRATEEK SHARMA, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier:
NCT00576498
First received: December 18, 2007
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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.

Condition Intervention
Barrett Esophagus
Gastroesophageal Reflux
Other: NBI-AFI imaging
Other: Standard Endoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Detection Of Intestinal Metaplasia And High Grade Dysplasia In Barrett's Esophagus Using Novel Imaging Techniques - A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Midwest Biomedical Research Foundation:

Primary Outcome Measures:
  • Proportion of patients with biopsy confirmed intestinal metaplasia [ Time Frame: 08/2006 to 10/2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Detection of high grade dysplasia [ Time Frame: 08/2006 to 10/2008 ] [ Designated as safety issue: No ]
  • Procedure time [ Time Frame: 08/2006 to 10/2008 ] [ Designated as safety issue: No ]
  • Number of biopsies [ Time Frame: 08/2006 to 10/2008 ] [ Designated as safety issue: No ]
  • Inter observer variability in reading of mucosal and vascular patterns [ Time Frame: 08/2006 to 10/2008 ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: October 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1- Narrow Band Imaging

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.

Autofluorescence Imaging (AFI)- 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)

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 Names:
  • NBI
  • AFI
2-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
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.
Other Name: EGD

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with suspected Barrett's esophagus on endoscopy
  • Age > 18 years
  • Ability to provide written informed consent

Exclusion Criteria:

  • Presence of erosive esophagitis
  • Visible nodules, lesions within Barrett's esophagus segment
  • Endoscopist aware of biopsy results
  • Inability to obtain biopsies due to anticoagulation or varices
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576498

Locations
United States, Missouri
Veterans Affairs Medical Center
Kansas city, Missouri, United States, 64128
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-2900
Netherlands
Academisch Medisch Centrum-Universiteit van Amsterdam (AMC-UvA)
Amsterdam, Netherlands
Sponsors and Collaborators
Midwest Biomedical Research Foundation
Kansas City Veteran Affairs Medical Center
Medical University of South Carolina
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: Prateek Sharma, MD Veterans Affairs Medical Center, Kansas City, MO; University of Kansas School of Medicine
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PRATEEK SHARMA, Professor of Medicine, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier: NCT00576498     History of Changes
Other Study ID Numbers: 00225(PS0036)
Study First Received: December 18, 2007
Last Updated: October 25, 2012
Health Authority: United States: Federal Government

Keywords provided by Midwest Biomedical Research Foundation:
GERD
NBI
AFI
IM
SSBE
LSBE
LGD
HGD

Additional relevant MeSH terms:
Barrett Esophagus
Gastroesophageal Reflux
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on April 23, 2014