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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Evaluation of a New EUS-guided Needle (ProCore) Comparing to Conventional EUS-TCB Needle (Quick-Core); A Prospective Randomized, Controlled Multi-center Study.

Conditions
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GIST

Intervention / Treatment
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* Device: EUS-TCB needle (QuickCore) standard of care
* Device: EUS-Guided biopsy needle (ProCore)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Solid tumors ≥ 2 cm in size. Exclusion criteria: Thrombocytopenia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EUS-Guided biopsy needle (ProCore)<br>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 | Device: EUS-Guided biopsy needle (ProCore)<br>* The number of needle passes requiring to acquire adequate specimen were tallied. Length of core tissue obtained Diagnostic contribution of immunohistochemical staining Rates of complications<br>* Other names: Comparison of core biopsy needles.;|
| Active Comparator: EUS-TCB needle (Quick-Core)<br>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 | Device: EUS-TCB needle (QuickCore) standard of care<br>* The number of needle passes requiring to acquire adequate specimen were tallied. Length of core tissue obtained Diagnostic contribution of immunohistochemical staining Rates of complications<br>* Other names: Comparison of core biopsy needles.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy. |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Specimen Length |  | 36 months | 
| Number of Needle Passes |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ProCore Needle