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Study Topics
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Sponsors and Collaborators: |
Kansas City Veteran Affairs Medical Center Medical University of South Carolina Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
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Information provided by: | Kansas City Veteran Affairs Medical Center |
ClinicalTrials.gov Identifier: | NCT00576498 |
Primary Aim: In patients with endoscopically suspected BE, compared to standard endoscopy, novel techniques (NBI and AFI) with target biopsies will
Secondary Aim:
Condition | Intervention |
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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. |
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 |
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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)
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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. |
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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
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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.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: April Higbee, RN | 8168614700 ext 57456 | april.higbee@va.gov |
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 |
Principal Investigator: | Prateek Sharma, MD | Veterans Affairs Medical Center, Kansas City, MO; University of Kansas School of Medicine |
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 |
GERD NBI AFI IM |
SSBE LSBE LGD HGD |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Digestive System Abnormalities Esophageal Disorder Barrett Syndrome |
Gastrointestinal Diseases Metaplasia Barrett Esophagus Esophageal Diseases Congenital Abnormalities Gastroesophageal Reflux |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Digestive System Abnormalities |
Gastrointestinal Diseases Barrett Esophagus Esophageal Diseases Gastroesophageal Reflux |