NCT02366858

Brief Summary

The investigators hypothesis is that a 22 gauge needle can yield core tissue, obviating the need to use the 19 gauge needle for core tissue procurement.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

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

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2014

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

January 15, 2014

Last Update Submit

February 13, 2017

Conditions

Pancreatic Cancer

Keywords

19 gauge22 gaugecore tissue

Outcome Measures

Primary Outcomes (1)

  • 22 gauge needle

    Compare the quality of core tissue specimens obtained between a 19G and 22G needle by evaluating the ability to perform molecular marker studies or immunohistochemistry studies between samples obtained.

    72 hours

Study Arms (2)

19 gauge

ACTIVE COMPARATOR

Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle.

Procedure: 19 gauge

22 gauge

ACTIVE COMPARATOR

Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle.

Procedure: 19 gaugeProcedure: 22 gauge

Interventions

19 gaugePROCEDURE

Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle

19 gauge22 gauge
22 gaugePROCEDURE

Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle

22 gauge

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who are referred to Florida Hospital Center for Interventional Endoscopy for a EUS FNA for core biopsy (19 gauge needle biopsy) who have needle dysfunction (This occurs in about 10% of patients)

You may not qualify if:

  • Age under 19 years
  • Pregnant women will be excluded. This will be confirmed by self-report

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida Hospital

Orlando, Florida, 32803, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Shyam Varadarajulu, MD

    AdventHealth

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2014

First Posted

February 19, 2015

Study Start

October 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 14, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)