EUS-FNA of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique (EUS-FNA)

April 11, 2017 updated by: University of Sao Paulo General Hospital

Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique

50 patients with pancreatic mass will undergo endoscopic ultrasound-guided fine needle aspiration using two techniques: negative pressure and slow-pull. Cytological results will be compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will analyze the cytological results of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic mass using two different techniques of needle suction. Negative pressure and slow-pull. 50 patients with pancreatic mass will be submitted to four passes with both techniques. Each patient will be randomized to decide which technique will be first and subsequently on a alternated fashion until four passes are completed. Smear cytology and cell block preparations for each technique were obtained. The pathologist was blinded for the EUS-FNA technique.

Study Type

Interventional

Enrollment (Actual)

1

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

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil
        • Hospital das Clínicas da FMUSP

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • pancreatic solid mass

Exclusion Criteria:

  • endoscopic ultrasound non accessible lesions

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: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EUS- FNA Slow-pull
Endoscopic ultrasound-guided fine needle aspiration using a stylet slow-pull technique of solid pancreatic mass
Procedure: Endoscopic ultrasound-guided fine needle aspiration
pancreatic solid mass punctured with a 22G endoscopic ultrasound needle
Other Names:
  • EUS-FNA
Active Comparator: EUS-FNA Negative Pressure
Endoscopic ultrasound-guided fine needle aspiration using negative pressure technique of solid pancreatic mass
Procedure: Endoscopic ultrasound-guided fine needle aspiration
pancreatic solid mass punctured with a 22G endoscopic ultrasound needle
Other Names:
  • EUS-FNA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic yield
Time Frame: 24 months
cytological results after endoscopic ultrasound fine needle aspiration
24 months

Collaborators and Investigators

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

Sponsor

University of Sao Paulo General Hospital

Collaborators

Boston Scientific Corporation
Medi - Globe

Investigators

  • Principal Investigator: Spencer Cheng, Hospital das Clinicas Faculdade de Medicina da Universidade de São Paulo

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 (Actual)

April 27, 2015

Primary Completion (Actual)

June 23, 2016

Study Completion (Actual)

June 23, 2016

Study Registration Dates

First Submitted

April 1, 2016

First Submitted That Met QC Criteria

April 11, 2017

First Posted (Actual)

April 12, 2017

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 41620315.9.0000.0068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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