Evaluation of Diagnostic Yield of EUS-Guided Tissue Sampling
NCT ID: NCT02979509
Last Updated: 2020-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
54 participants
OBSERVATIONAL
2016-06-30
2019-08-30
Brief Summary
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Detailed Description
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Aim - To prospectively evaluate the safety and diagnostic yield of the through-the-needle microforceps for pancreatic and non-pancreatic solid, cystic and mixed solid/cystic lesions.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Endoscopic ultrasound- (EUS) guided tissue sampling
All patients scheduled to undergo EUS with tissue sampling (TS) as medically indicated will be considered for the study. Patients in whom EUS-TS is considered as part of their standard medical care will be offered to participate in this study.
Endoscopic ultrasound- (EUS) guided tissue sampling
EUS- guided tissue sampling of solid and/or cystic pancreatic and non-pancreatic lesions as part of their medical care.
Interventions
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Endoscopic ultrasound- (EUS) guided tissue sampling
EUS- guided tissue sampling of solid and/or cystic pancreatic and non-pancreatic lesions as part of their medical care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients referred for EUS-guided tissue sampling for lesions (i.e. pancreas, liver, mediastinal masses, left adrenal gland, lymph nodes, and subepithelial lesions).
3. Target lesion should be ≥ 15 mm in size (long axis).
Exclusion Criteria
2. Unable to provide informed consent
18 Years
100 Years
ALL
Yes
Sponsors
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Borland Groover Clinic, Jacksonville, FL
UNKNOWN
Northwestern University, Chicago, IL
UNKNOWN
Mayo Clinic
OTHER
Montefiore Medical Center, Bronx, NY
UNKNOWN
Columbia University
OTHER
Johns Hopkins University
OTHER
New York University, New York, NY
UNKNOWN
Yale University
OTHER
Geisinger Medical Center, Danville, PA
UNKNOWN
Ochsner Health System
OTHER
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Dennis Yang, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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References
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Yang D, Trindade AJ, Yachimski P, Benias P, Nieto J, Manvar A, Ho S, Esnakula A, Gamboa A, Sethi A, Gupte A, Khara HS, Diehl DL, El Chafic A, Shah J, Forsmark CE, Draganov PV. Histologic Analysis of Endoscopic Ultrasound-Guided Through the Needle Microforceps Biopsies Accurately Identifies Mucinous Pancreas Cysts. Clin Gastroenterol Hepatol. 2019 Jul;17(8):1587-1596. doi: 10.1016/j.cgh.2018.11.027. Epub 2018 Nov 22.
Other Identifiers
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IRB201600783
Identifier Type: -
Identifier Source: org_study_id
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