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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
  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
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

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: August 9, 2012
Last Updated: October 23, 2015
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 29, 2016