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Comparing Methods to Biopsy Pancreas Mass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01663493
First Posted: August 13, 2012
Last Update Posted: February 14, 2017
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.
Information provided by (Responsible Party):
Linda S. Lee, Brigham and Women's Hospital
  Purpose
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

  Eligibility

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
Criteria

Inclusion Criteria:

  • adult
  • pancreas mass

Exclusion Criteria:

  • coagulopathy
  • mass not approachable by endoscopic ultrasound biopsy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01663493


Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT01663493     History of Changes
Other Study ID Numbers: 2012-P-000955/1
First Submitted: August 9, 2012
First Posted: August 13, 2012
Last Update Posted: February 14, 2017
Last Verified: February 2017