Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
NCT ID: NCT01769248
Last Updated: 2018-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2012-09-30
2014-02-28
Brief Summary
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The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.
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Detailed Description
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We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140 patients with the primary outcome being diagnostic yield. Each patient will be randomized to FNA or FNA. If after 3 passes the on-site evaluation remains inadequate, the endoscopist will crossover to the other arm.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Fine needle aspiration
fine needle aspiration
Fine needle aspiration
Fine needle aspiration
Fine needle biopsy
FNB
Fine needle biopsy
Fine needle biopsy
Fine needle aspiration
Fine needle aspiration
Fine needle biopsy
FNB
Interventions
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Fine needle aspiration
Fine needle aspiration
Fine needle biopsy
FNB
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3.2.2 Diagnostic EUS determines lesion is not amenable to FNA or FNB
18 Years
90 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Sri Komanduri
Associate Professor of Medicine
Principal Investigators
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Srinadh Komanduri
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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UCLA Medical Center
Los Angeles, California, United States
California Pacific Medical Center
San Francisco, California, United States
Moffit Cancer Center
Tampa, Florida, United States
Countries
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Other Identifiers
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FNAFNBmucin
Identifier Type: -
Identifier Source: org_study_id
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