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EUS-FNA With and Without Suction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02072915
First Posted: February 27, 2014
Last Update Posted: November 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Alabama at Birmingham
  Purpose
To compare the number of passes required for cellblock acquisition with and without suction using the 25g needle.

Condition Intervention
Solid Pancreatic Mass Lesions Procedure: Suction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Randomized Single Blind Controlled Trial of EUS-FNA With and Without Suction for Adequate Cellblock Sample Procurement of Solid Pancreatic Mass Lesions Using 25G Needle

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Number of passes [ Time Frame: once at baseline ]

Enrollment: 72
Study Start Date: January 2014
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Suction
Suction will be applied to patients undergoing EUS-FNA
Procedure: Suction
No Intervention: Without suction
No suction will be applied to patients undergoing EUS-FNA

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients referred to UAB Endoscopy Unit for assessment of pancreatic mass lesions that requires FNA.

Exclusion Criteria:

  • Age < 19 years

    • Unable to safely undergo EUS for any reason
    • Coagulopathy (INR>1.6, Prothrombin Time>18 secs, Thrombocytopenia < 80,000 cells/ml)
    • Unable to consent
    • Non-English speaking patients
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072915


Locations
United States, Alabama
UAB
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Jayapal Ramesh, MD University of Alabama at Birmingham
  More Information

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02072915     History of Changes
Other Study ID Numbers: F131108005
First Submitted: February 25, 2014
First Posted: February 27, 2014
Last Update Posted: November 10, 2014
Last Verified: November 2014