Pancreatic Core Biopsy Needle Study in Patients Suspected of Pancreatic Malignancy
NCT ID: NCT03016637
Last Updated: 2017-01-11
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
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2016-01-31
2016-12-31
Brief Summary
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Detailed Description
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SharkCore (TM) is a new type of EUS fine needle that allows the extraction of macroscopic tissue fractions ("trucut biopsies") instead of single cells or cluster of cells. Preliminary data suggest that EUS guided trucut biopsies from the pancreatic lesions are technically feasible without increasing the number of complications.
This prospective study evaluates the clinical outcome and potential complications following EUS guided biopsy of pancreatic lesions suspected of cancer using a 25 Gauge or 22 Gauge SharkCore needle.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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EUS biopsy
EUS guided SharkCore (TM) biopsy of pancreatic lesions suspected of malignancy
SharkCore (TM) FNB Exchange System
Interventions
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SharkCore (TM) FNB Exchange System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Responsible Party
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Michael Bau Mortensen
Professor
Principal Investigators
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Michael B Mortensen, Professor
Role: STUDY_DIRECTOR
Odense University Hospital, University of Southern denmark
Locations
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Odense University Hospital
Odense, Odense, Denmark
Countries
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References
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Hewitt MJ, McPhail MJ, Possamai L, Dhar A, Vlavianos P, Monahan KJ. EUS-guided FNA for diagnosis of solid pancreatic neoplasms: a meta-analysis. Gastrointest Endosc. 2012 Feb;75(2):319-31. doi: 10.1016/j.gie.2011.08.049.
Bardales RH, Stelow EB, Mallery S, Lai R, Stanley MW. Review of endoscopic ultrasound-guided fine-needle aspiration cytology. Diagn Cytopathol. 2006 Feb;34(2):140-75. doi: 10.1002/dc.20300.
Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.
Bang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31.
Mortensen MB, Fristrup C, Holm FS, Pless T, Durup J, Ainsworth AP, Nielsen HO, Hovendal C. Prospective evaluation of patient tolerability, satisfaction with patient information, and complications in endoscopic ultrasonography. Endoscopy. 2005 Feb;37(2):146-53. doi: 10.1055/s-2005-861142.
Other Identifiers
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MBM-71
Identifier Type: -
Identifier Source: org_study_id
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