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Comparing Methods to Biopsy Pancreas Mass

This study has been completed.
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: February 11, 2017
Last verified: February 2017
  Purpose
This study will examine whether there is any difference in number of passes needed to diagnose pancreatic masses during endoscopic ultrasound-guided biopsies using 2 different types of needles.

Condition Intervention
Pancreas Mass Diagnosis
Procedure: FNB

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Randomized Trial Comparing 2 Needles During EUS-FNA of Solid Pancreatic Masses

Resource links provided by NLM:


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

Primary Outcome Measures:
  • number of passes [ Time Frame: 1 week ]

Enrollment: 59
Actual Study Start Date: October 2015
Study Completion Date: February 2017
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fine needle aspiration needle
standard Beacon FNA needle
Procedure: FNB
fine needle biopsy needle
SharkCore fine needle biopsy needle
Procedure: FNB

  Eligibility

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

Inclusion Criteria:

  • adult
  • pancreas mass

Exclusion Criteria:

  • coagulopathy
  • mass not 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: February 11, 2017

ClinicalTrials.gov processed this record on February 20, 2017