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

NCT ID: NCT03111368

Last Updated: 2017-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-27

Study Completion Date

2016-06-23

Brief Summary

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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

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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.

Conditions

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Pancreatic Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EUS- FNA Slow-pull

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

Group Type ACTIVE_COMPARATOR

Endoscopic ultrasound-guided fine needle aspiration

Intervention Type PROCEDURE

pancreatic solid mass punctured with a 22G endoscopic ultrasound needle

EUS-FNA Negative Pressure

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

Group Type ACTIVE_COMPARATOR

Endoscopic ultrasound-guided fine needle aspiration

Intervention Type PROCEDURE

pancreatic solid mass punctured with a 22G endoscopic ultrasound needle

Interventions

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Endoscopic ultrasound-guided fine needle aspiration

pancreatic solid mass punctured with a 22G endoscopic ultrasound needle

Intervention Type PROCEDURE

Other Intervention Names

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EUS-FNA

Eligibility Criteria

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Inclusion Criteria

* pancreatic solid mass

Exclusion Criteria

* endoscopic ultrasound non accessible lesions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Medi - Globe

UNKNOWN

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Spencer Cheng

Role: PRINCIPAL_INVESTIGATOR

Hospital das Clinicas Faculdade de Medicina da Universidade de São Paulo

Locations

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Hospital das Clinicas da FMUSP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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41620315.9.0000.0068

Identifier Type: -

Identifier Source: org_study_id

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