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Comparing Methods to Biopsy Pancreas Mass

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Linda S. Lee, Brigham and Women's Hospital Identifier:
First received: August 9, 2012
Last updated: October 23, 2015
Last verified: October 2015
This study will examine whether there is any difference in diagnostic yield from doing endoscopic ultrasound-guided biopsies of pancreas masses with a cytologist present during the procedure or without one present.

Condition Intervention
Pancreas Mass Diagnostic Yield
Procedure: Cytologist present

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Randomized Noninferiority Trial Comparing Diagnostic Yield of Cytopathologist-guided Versus 7 Passes During EUS-FNA of Solid Pancreatic Masses

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • diagnostic yield [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: August 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
cytologist present
cytologist present
Procedure: Cytologist present
no cytologist
no cytologist present
Procedure: Cytologist present


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

Inclusion Criteria:

  • adult
  • pancreas mass

Exclusion Criteria:

  • coagulopathy
  • mass 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: October 23, 2015
Health Authority: United States: Institutional Review Board processed this record on January 18, 2017