NCT03111368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
Last Updated

April 12, 2017

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

April 1, 2016

Last Update Submit

April 11, 2017

Conditions

Pancreatic Neoplasm

Keywords

eus-fnapancreatic neoplasmslow-pullnegative pressure

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield

    cytological results after endoscopic ultrasound fine needle aspiration

    24 months

Study Arms (2)

EUS- FNA Slow-pull

ACTIVE COMPARATOR

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

Procedure: Endoscopic ultrasound-guided fine needle aspiration

EUS-FNA Negative Pressure

ACTIVE COMPARATOR

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

Procedure: Endoscopic ultrasound-guided fine needle aspiration

Interventions

Endoscopic ultrasound-guided fine needle aspirationPROCEDURE

pancreatic solid mass punctured with a 22G endoscopic ultrasound needle

Also known as: EUS-FNA
EUS- FNA Slow-pullEUS-FNA Negative Pressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pancreatic solid mass

You may not qualify if:

  • endoscopic ultrasound non accessible lesions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas da FMUSP

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-NeedleBiopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisImage-Guided BiopsySpecimen HandlingUltrasonography, InterventionalUltrasonographyDiagnostic ImagingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Spencer Cheng

    Hospital das Clinicas Faculdade de Medicina da Universidade de São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 12, 2017

Study Start

April 27, 2015

Primary Completion

June 23, 2016

Study Completion

June 23, 2016

Last Updated

April 12, 2017

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)