Comparing Methods to Biopsy Pancreas Mass

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01663493
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : February 14, 2017
Information provided by (Responsible Party):
Linda S. Lee, Brigham and Women's Hospital

Brief Summary:
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 or disease Intervention/treatment
Pancreas Mass Diagnosis Procedure: FNB

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
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
Actual Study Start Date : October 2015
Primary Completion Date : December 2016
Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arm Intervention/treatment
Fine needle aspiration needle
standard Beacon FNA needle
Procedure: FNB
fine needle biopsy needle
SharkCore fine needle biopsy needle
Procedure: FNB

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017