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Comparing Methods to Biopsy Pancreas Mass

This study is ongoing, but not recruiting participants.
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: October 23, 2015
Last verified: October 2015

August 9, 2012
October 23, 2015
August 2012
December 2015   (final data collection date for primary outcome measure)
diagnostic yield [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01663493 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Comparing Methods to Biopsy Pancreas Mass
Randomized Noninferiority Trial Comparing Diagnostic Yield of Cytopathologist-guided Versus 7 Passes During EUS-FNA of Solid Pancreatic Masses
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.
Not Provided
Interventional
Not Provided
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.
 
Active, not recruiting
140
December 2015
December 2015   (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 to 100 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01663493
2012-P-000955/1
No
Not Provided
Not Provided
Linda S. Lee, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Linda S Lee Brigham and Women's Hospital
Brigham and Women's Hospital
October 2015

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