Evaluation of a New EUS-guided Needle (ProCore) Comparing to EUS-TCB Needle (Quick-Core)

Indiana University

Status: Completed

Conditions: GIST

Treatments: Device: EUS-TCB needle (QuickCore) standard of care; Device: EUS-Guided biopsy needle (ProCore)

Study type: Interventional

Funder types: Other

Identifiers

NCT01768325

1104-03

Details and patient eligibility

About

The purpose of this study is to evaluate a new EUS-guided biopsy needle (ProCore®) comparing it to conventional EUS-TCB needle (Quick-Core®) in the diagnosis of your suspicious disorder.

This study needle (ProCore®) is a new EUS-guided biopsy needle and has been recently approved by the U.S. Food and Drug Administration (FDA) for use.

Full description

Primary Objective To compare the diagnostic accuracy of new EUS histology needle (19G, ProCore, Cook Medical Inc., Winston-Salem, NC) with the conventional histology needle (19G, Quick-Core, Cook Medical Inc., Winston-Salem, NC)

Secondary Objective To compare

• The number of needle passes requiring to acquire adequate specimen
• Length of core tissue obtained
• Diagnostic contribution of immunohistochemical staining
• Rates of complications

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Solid tumors ≥ 2 cm in size.

Exclusion criteria

• Thrombocytopenia

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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85 participants in 2 patient groups

EUS-Guided biopsy needle (ProCore)

Active Comparator group

Description:

Comparison of ProCore core biopsy needle to QuickCore core biopsy needle.Cook Medical core biopsy needle. * The number of needle passes requiring to acquire adequate specimen * Length of core tissue obtained * Diagnostic contribution of immunohistochemical staining * Rates of complications

Treatment:

Device: EUS-Guided biopsy needle (ProCore)

EUS-TCB needle (Quick-Core)

Active Comparator group

Description:

Comparison of core biopsy needles. * The number of needle passes requiring to acquire adequate specimen * Length of core tissue obtained * Diagnostic contribution of immunohistochemical staining * Rates of complications

Treatment:

Device: EUS-TCB needle (QuickCore) standard of care