Novel Imaging Techniques in Barrett's Esophagus - Full Text View

Sponsor:	Kansas City Veteran Affairs Medical Center
Collaborators:	Medical University of South Carolina Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by:	Kansas City Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00576498

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:	Diagnostic, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Efficacy Study
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:

MedlinePlus related topics: Endoscopy GERD

U.S. FDA Resources

Further study details as provided by Kansas City Veteran Affairs Medical Center:

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 ]

Estimated Enrollment:	130
Study Start Date:	August 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Narrow Band Imaging- Patients will be evaluated with a standard magnification endoscope (Olympus GIF Q240Z, 115x) using a NBI light source. 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)	Other: NBI-AFI imaging Narrow Band Imaging- Patients will be evaluated with a standard magnification endoscope (Olympus GIF Q240Z, 115x) 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.
2 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.

Arms

Assigned Interventions

1: Experimental

Narrow Band Imaging- Patients will be evaluated with a standard magnification endoscope (Olympus GIF Q240Z, 115x) using a NBI light source.

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)

Other: NBI-AFI imaging

Narrow Band Imaging- Patients will be evaluated with a standard magnification endoscope (Olympus GIF Q240Z, 115x) 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.

2

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.

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

Contacts

Contact: April Higbee, RN

8168614700 ext 57456

april.higbee@va.gov

Locations

United States, Missouri
Veterans Affairs Medical Center	Recruiting
Kansas city, Missouri, United States, 64128
Contact: April Higbee, RN 816-861-4700 ext 57456
Sub-Investigator: Ajay Bansal, MD
Sub-Investigator: Amit Rastogi, MD
Sub-Investigator: Prashant Pandya, DO
Sub-Investigator: Sharad Mathur, MD
Principal Investigator: Prateek Sharma, MD
Sub-Investigator: Sachin Wani, MD

Sponsors and Collaborators

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:

Weinstein WM, Ippoliti AF. The diagnosis of Barrett's esophagus: goblets, goblets, goblets. Gastrointest Endosc. 1996 Jul;44(1):91-5. No abstract available.

Devesa SS, Blot WJ, Fraumeni JF Jr. Changing patterns in the incidence of esophageal and gastric carcinoma in the United States. Cancer. 1998 Nov 15;83(10):2049-53.

Brown LM, Devesa SS. Epidemiologic trends in esophageal and gastric cancer in the United States. Surg Oncol Clin N Am. 2002 Apr;11(2):235-56. Review.

Gerson LB, Shetler K, Triadafilopoulos G. Prevalence of Barrett's esophagus in asymptomatic individuals. Gastroenterology. 2002 Aug;123(2):461-7.

Rex DK, Cummings OW, Shaw M, Cumings MD, Wong RK, Vasudeva RS, Dunne D, Rahmani EY, Helper DJ. Screening for Barrett's esophagus in colonoscopy patients with and without heartburn. Gastroenterology. 2003 Dec;125(6):1670-7.

Hamilton SR, Smith RR, Cameron JL. Prevalence and characteristics of Barrett esophagus in patients with adenocarcinoma of the esophagus or esophagogastric junction. Hum Pathol. 1988 Aug;19(8):942-8.

Sampliner RE. Practice guidelines on the diagnosis, surveillance, and therapy of Barrett's esophagus. The Practice Parameters Committee of the American College of Gastroenterology. Am J Gastroenterol. 1998 Jul;93(7):1028-32. No abstract available.

Sharma P, McQuaid K, Dent J, Fennerty MB, Sampliner R, Spechler S, Cameron A, Corley D, Falk G, Goldblum J, Hunter J, Jankowski J, Lundell L, Reid B, Shaheen NJ, Sonnenberg A, Wang K, Weinstein W; AGA Chicago Workshop. A critical review of the diagnosis and management of Barrett's esophagus: the AGA Chicago Workshop. Gastroenterology. 2004 Jul;127(1):310-30. Review.

Eloubeidi MA, Provenzale D. Does this patient have Barrett's esophagus? The utility of predicting Barrett's esophagus at the index endoscopy. Am J Gastroenterol. 1999 Apr;94(4):937-43.

Inadomi JM, Sampliner R, Lagergren J, Lieberman D, Fendrick AM, Vakil N. Screening and surveillance for Barrett esophagus in high-risk groups: a cost-utility analysis. Ann Intern Med. 2003 Feb 4;138(3):176-86.

Cameron AJ, Carpenter HA. Barrett's esophagus, high-grade dysplasia, and early adenocarcinoma: a pathological study. Am J Gastroenterol. 1997 Apr;92(4):586-91.

Responsible Party:	Kansas city VA Medical Center ( PRATEEK SHARMA )
Study ID Numbers:	00225(PS0036)
Study First Received:	December 18, 2007
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00576498 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Kansas City Veteran Affairs Medical Center:

GERD
NBI
AFI
IM

SSBE
LSBE
LGD
HGD

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Digestive System Abnormalities

Gastrointestinal Diseases
Barrett Esophagus
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on November 30, 2009