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

August 9, 2012
August 9, 2012
August 2012
December 2013   (final data collection date for primary outcome measure)
diagnostic yield [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
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Comparing Methods to Biopsy Pancreas Mass
Not Provided

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Pancreas Mass Diagnostic Yield
Procedure: Cytologist present
  • cytologist present
    cytologist present
    Intervention: Procedure: Cytologist present
  • no cytologist
    no cytologist present
    Intervention: Procedure: Cytologist present
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
Not Provided
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult
  • pancreas mass

Exclusion Criteria:

  • coagulopathy
  • mass approachable by endoscopic ultrasound biopsy
Both
18 Years and older
No
Contact: Linda S Lee, MD 617-732-7429
United States
 
NCT01663493
2012-P-000955/1
Not Provided
Linda S. Lee, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Not Provided
Brigham and Women's Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP