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Comparing Methods to Biopsy Pancreas Mass

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

Condition Intervention
Pancreas Mass Diagnosis Procedure: FNB

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Trial Comparing 2 Needles During EUS-FNA of Solid Pancreatic Masses

Resource links provided by NLM:

Further study details as provided by Linda S. Lee, Brigham and Women's Hospital:

Primary Outcome Measures:
  • number of passes [ Time Frame: 1 week ]

Enrollment: 59
Actual Study Start Date: October 2015
Study Completion Date: February 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fine needle aspiration needle
standard Beacon FNA needle
Procedure: FNB
fine needle biopsy needle
SharkCore fine needle biopsy needle
Procedure: FNB


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult
  • pancreas mass

Exclusion Criteria:

  • coagulopathy
  • mass not approachable by endoscopic ultrasound biopsy
  Contacts and Locations
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Please refer to this study by its identifier: NCT01663493

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Linda S Lee Brigham and Women's Hospital
  More Information

Responsible Party: Linda S. Lee, Assistant Professor of Medicine, Brigham and Women's Hospital Identifier: NCT01663493     History of Changes
Other Study ID Numbers: 2012-P-000955/1
Study First Received: August 9, 2012
Last Updated: February 11, 2017 processed this record on September 21, 2017