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

Primary Purpose

Pancreatic Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Endoscopic ultrasound-guided fine needle aspiration
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Neoplasm focused on measuring eus-fna, pancreatic neoplasm, slow-pull, negative pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • pancreatic solid mass

Exclusion Criteria:

  • endoscopic ultrasound non accessible lesions

Sites / Locations

  • Hospital das Clinicas da FMUSP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

EUS- FNA Slow-pull

EUS-FNA Negative Pressure

Arm Description

Endoscopic ultrasound-guided fine needle aspiration using a stylet slow-pull technique of solid pancreatic mass

Endoscopic ultrasound-guided fine needle aspiration using negative pressure technique of solid pancreatic mass

Outcomes

Primary Outcome Measures

Diagnostic yield
cytological results after endoscopic ultrasound fine needle aspiration

Secondary Outcome Measures

Full Information

First Posted
April 1, 2016
Last Updated
April 11, 2017
Sponsor
University of Sao Paulo General Hospital
Collaborators
Boston Scientific Corporation, Medi - Globe
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1. Study Identification

Unique Protocol Identification Number
NCT03111368
Brief Title
EUS-FNA of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique
Acronym
EUS-FNA
Official Title
Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
April 27, 2015 (Actual)
Primary Completion Date
June 23, 2016 (Actual)
Study Completion Date
June 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Boston Scientific Corporation, Medi - Globe

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasm
Keywords
eus-fna, pancreatic neoplasm, slow-pull, negative pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EUS- FNA Slow-pull
Arm Type
Active Comparator
Arm Description
Endoscopic ultrasound-guided fine needle aspiration using a stylet slow-pull technique of solid pancreatic mass
Arm Title
EUS-FNA Negative Pressure
Arm Type
Active Comparator
Arm Description
Endoscopic ultrasound-guided fine needle aspiration using negative pressure technique of solid pancreatic mass
Intervention Type
Procedure
Intervention Name(s)
Endoscopic ultrasound-guided fine needle aspiration
Other Intervention Name(s)
EUS-FNA
Intervention Description
pancreatic solid mass punctured with a 22G endoscopic ultrasound needle
Primary Outcome Measure Information:
Title
Diagnostic yield
Description
cytological results after endoscopic ultrasound fine needle aspiration
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: pancreatic solid mass Exclusion Criteria: endoscopic ultrasound non accessible lesions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Spencer Cheng
Organizational Affiliation
Hospital das Clinicas Faculdade de Medicina da Universidade de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clinicas da FMUSP
City
Sao Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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