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EUS-FNA With and Without Suction

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ClinicalTrials.gov Identifier: NCT02072915
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : November 10, 2014
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham

Brief Summary:
To compare the number of passes required for cellblock acquisition with and without suction using the 25g needle.

Condition or disease Intervention/treatment Phase
Solid Pancreatic Mass Lesions Procedure: Suction Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
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
Study Start Date : January 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
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



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


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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

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

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