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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014