Study Results
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View full resultsBasic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2012-08-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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19G FNA needle
Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 19G FNA needle when performing pancreatic biopsy.
Pancreatic Biopsy
A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
Histological Samples
The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.
25G FNA needle
Evaluate median number of passes to diagnosis (Diagnostic accuracy) and ability to procure histological samples using a 25G FNA needle when performing pancreatic biopsy.
Pancreatic Biopsy
A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
Histological Samples
The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.
Interventions
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Pancreatic Biopsy
A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
Histological Samples
The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Unable to safely undergo EUS for any reason
3. Coagulopathy (INR \> 1.6, Prothrombin Time \> 18secs, Thrombocytopenia \< 80,000 cells/ml)
4. Unable to consent
5. Non-English speaking patients
19 Years
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
AdventHealth
OTHER
Responsible Party
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Principal Investigators
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shyam varadarajulu, MD
Role: PRINCIPAL_INVESTIGATOR
Florida Hospital Center for Interventional Endoscopy
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Florida Hospital
Orlando, Florida, United States
Countries
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Other Identifiers
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356077
Identifier Type: -
Identifier Source: org_study_id
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