NCT00576498

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

October 29, 2012

Status Verified

October 1, 2012

Enrollment Period

3.6 years

First QC Date

December 18, 2007

Last Update Submit

October 25, 2012

Conditions

Barrett EsophagusGastroesophageal Reflux

Keywords

GERDNBIAFIIMSSBELSBELGDHGD

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with biopsy confirmed intestinal metaplasia

    08/2006 to 10/2008

Secondary Outcomes (4)

  • Detection of high grade dysplasia

    08/2006 to 10/2008

  • Procedure time

    08/2006 to 10/2008

  • Number of biopsies

    08/2006 to 10/2008

  • Inter observer variability in reading of mucosal and vascular patterns

    08/2006 to 10/2008

Study Arms (2)

1- Narrow Band Imaging

EXPERIMENTAL

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

2-Standard Endoscopy

OTHER

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

Interventions

NBI-AFI imagingOTHER

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.

Also known as: NBI, AFI
1- Narrow Band Imaging
Standard EndoscopyOTHER

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.

Also known as: EGD
2-Standard Endoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Veterans Affairs Medical Center

Kansas City, Missouri, 64128, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-2900, United States

Location

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

Amsterdam, Netherlands

Location

Related Publications (12)

  • Weinstein WM, Ippoliti AF. The diagnosis of Barrett's esophagus: goblets, goblets, goblets. Gastrointest Endosc. 1996 Jul;44(1):91-5. doi: 10.1016/s0016-5107(96)70239-0. No abstract available.

    PMID: 8836727BACKGROUND

  • 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.

    PMID: 9827707BACKGROUND

  • 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. doi: 10.1016/s1055-3207(02)00002-9.

    PMID: 12424848BACKGROUND

  • Gerson LB, Shetler K, Triadafilopoulos G. Prevalence of Barrett's esophagus in asymptomatic individuals. Gastroenterology. 2002 Aug;123(2):461-7. doi: 10.1053/gast.2002.34748.

    PMID: 12145799BACKGROUND

  • 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. doi: 10.1053/j.gastro.2003.09.030.

    PMID: 14724819BACKGROUND

  • 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. doi: 10.1016/s0046-8177(88)80010-8.

    PMID: 3402983BACKGROUND

  • 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. doi: 10.1111/j.1572-0241.1998.00362.x. No abstract available.

    PMID: 9672324BACKGROUND

  • 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. doi: 10.1053/j.gastro.2004.04.010.

    PMID: 15236196BACKGROUND

  • 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. doi: 10.1111/j.1572-0241.1999.990_m.x.

    PMID: 10201460BACKGROUND

  • 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. doi: 10.7326/0003-4819-138-3-200302040-00009.

    PMID: 12558356BACKGROUND

  • 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.

    PMID: 9128304BACKGROUND

  • Sharma P, Hawes RH, Bansal A, Gupta N, Curvers W, Rastogi A, Singh M, Hall M, Mathur SC, Wani SB, Hoffman B, Gaddam S, Fockens P, Bergman JJ. Standard endoscopy with random biopsies versus narrow band imaging targeted biopsies in Barrett's oesophagus: a prospective, international, randomised controlled trial. Gut. 2013 Jan;62(1):15-21. doi: 10.1136/gutjnl-2011-300962. Epub 2012 Feb 7.

    PMID: 22315471DERIVED

MeSH Terms

Conditions

Barrett EsophagusGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesEsophageal Motility DisordersDeglutition Disorders

Study Officials

  • Prateek Sharma, MD

    Veterans Affairs Medical Center, Kansas City, MO; University of Kansas School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 19, 2007

Study Start

October 1, 2005

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

October 29, 2012

Record last verified: 2012-10

Locations

US(2)NL(1)