EUS-FNA With and Without Suction

November 7, 2014 updated by: University of Alabama at Birmingham

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • UAB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of passes
Time Frame: once at baseline
once at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Jayapal Ramesh, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

February 25, 2014

First Submitted That Met QC Criteria

February 26, 2014

First Posted (Estimate)

February 27, 2014

Study Record Updates

Last Update Posted (Estimate)

November 10, 2014

Last Update Submitted That Met QC Criteria

November 7, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • F131108005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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