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Comparing Methods to Biopsy Pancreas Mass

This study is currently recruiting participants.
Verified August 2012 by Brigham and Women's Hospital
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: NA
Last verified: August 2012
History: No changes posted
  Purpose

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

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 Primary Completion Date: December 2013 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult
  • pancreas mass

Exclusion Criteria:

  • coagulopathy
  • mass approachable by endoscopic ultrasound biopsy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663493

Contacts
Contact: Linda S Lee, MD 617-732-7429

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
  More Information

No publications provided

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
Study First Received: August 9, 2012
Last Updated: August 9, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013