NCT01394159

Brief Summary

The aim of this research study is to identify the best needle for performing biopsy during EUS procedures. There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a 22G ProCore needle that provides larger amount of tissue. It is not clear at this point which of the two needles is superior for performing biopsy. This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

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

July 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

April 1, 2015

Completed
Last Updated

March 9, 2018

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

July 12, 2011

Results QC Date

March 18, 2015

Last Update Submit

February 9, 2018

Conditions

Pancreatic Neoplasm

Keywords

passes required to establish diagnosis

Outcome Measures

Primary Outcomes (1)

  • Compare the Median Number of Passes Required to Establish a Diagnosis

    6 months

Secondary Outcomes (2)

  • Diagnosis Achieved With the Needle

    6 months

  • Technical Failure

    6 months

Study Arms (2)

22G ProCore biopsy needle

ACTIVE COMPARATOR

Using the 22G ProCore needle for sampling pancreatic mass lesions, the tissue obtained will be compared to the standard FNA needle.

Procedure: 22G ProCore biopsy needle

22G standard FNA needle

ACTIVE COMPARATOR

Using the 22G standard fine needle aspiration needle (FNA) for sampling pancreatic mass lesions, the tissue obtained will be compared to the 22 G ProCore needle.

Procedure: 22G standard FNA needle

Interventions

22G ProCore biopsy needlePROCEDURE

Tissue will be acquired with the 22G Procore biopsy needle and the sample will be compared to the sample obtained with the 22G standard FNA needle.

Also known as: Biopsy
22G ProCore biopsy needle
22G standard FNA needlePROCEDURE

Tissue will be acquired with the 22G standard FNA biopsy needle and the sample will be compared to the sample obtained with the 22G ProCore biopsy needle.

Also known as: biopsy
22G standard FNA needle

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with solid pancreatic mass lesions

You may not qualify if:

  • Coaguloapthy,
  • minors,
  • prgenant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • Bang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31.

    PMID: 22658389DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Results Point of Contact

Title
Dr Shyam Varadarajulu
Organization
Center for Interventional Endoscopy, Florida Hospital
svaradarajulu@yahoo.com
407-303-2570

Study Officials

  • Shyam Varadarajulu, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

July 12, 2011

First Posted

July 14, 2011

Study Start

July 1, 2011

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

March 9, 2018

Results First Posted

April 1, 2015

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)