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Comparing Methods to Biopsy Pancreas Mass

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Linda S. Lee, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01663493
First received: August 9, 2012
Last updated: February 11, 2017
Last verified: February 2017

August 9, 2012
February 11, 2017
October 2015
December 2016   (Final data collection date for primary outcome measure)
number of passes [ Time Frame: 1 week ]
diagnostic yield [ Time Frame: 1 week ]
Complete list of historical versions of study NCT01663493 on ClinicalTrials.gov Archive Site
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Comparing Methods to Biopsy Pancreas Mass
Randomized Trial Comparing 2 Needles During EUS-FNA of Solid Pancreatic Masses
This study will examine whether there is any difference in number of passes needed to diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different types of needles.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Diagnostic
Pancreas Mass Diagnosis
Procedure: FNB
  • Fine needle aspiration needle
    standard Beacon FNA needle
    Intervention: Procedure: FNB
  • fine needle biopsy needle
    SharkCore fine needle biopsy needle
    Intervention: Procedure: FNB
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
February 2017
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult
  • pancreas mass

Exclusion Criteria:

  • coagulopathy
  • mass not approachable by endoscopic ultrasound biopsy
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01663493
2012-P-000955/1
No
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Linda S. Lee, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Linda S Lee Brigham and Women's Hospital
Brigham and Women's Hospital
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP