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

Not Applicable

Completed

• Conditions: Pancreatic Neoplasm
• Interventions: Procedure: Endoscopic ultrasound-guided fine needle aspiration

• Registration Number: NCT03111368
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-04-27
• Study First Submitted: 2016-04-01
• Status Verified: 2016-06
• Primary Completion: 2016-06-23
• Study Completion: 2016-06-23
• Study First Submitted QC: 2017-04-11
• Last Update Submitted: 2017-04-11
• Study First Posted: 2017-04-12
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• pancreatic solid mass

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Exclusion Criteria

• endoscopic ultrasound non accessible lesions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS- FNA Slow-pull	Endoscopic ultrasound-guided fine needle aspiration	Endoscopic ultrasound-guided fine needle aspiration using a stylet slow-pull technique of solid pancreatic mass
EUS-FNA Negative Pressure	Endoscopic ultrasound-guided fine needle aspiration	Endoscopic ultrasound-guided fine needle aspiration using negative pressure technique of solid pancreatic mass

Primary Outcome Measures

Name	Time	Method
Diagnostic yield	24 months	cytological results after endoscopic ultrasound fine needle aspiration

Trial Locations

Locations (1)

Hospital das Clinicas da FMUSP; 🇧🇷 Sao Paulo, SP, Brazil