GIST
Conditions
Keywords
ProCore Needle
Brief summary
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
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
Interventions
DEVICEEUS-TCB needle (QuickCore) standard of care
* 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
DEVICEEUS-Guided biopsy needle (ProCore)
* 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
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Solid tumors ≥ 2 cm in size.
Exclusion criteria
* Thrombocytopenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic Accuracy. | 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Overall Specimen Length | 36 months |
| Number of Needle Passes | 36 months |
Countries
United States
Participant flow
Pre-assignment details
85 participants were enrolled in this study but only 78 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| QuickCore Needle | 37 |
| ProCore Needle | 41 |
| Total | 78 |
Baseline characteristics
| Characteristic | QuickCore Needle | ProCore Needle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 41 Participants | 78 Participants |
| Region of Enrollment United States | 37 participants | 41 participants | 78 participants |
| Sex: Female, Male Female | 18 Participants | 17 Participants | 35 Participants |
| Sex: Female, Male Male | 19 Participants | 24 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 37 | 3 / 41 |
| serious Total, serious adverse events | 0 / 37 | 0 / 41 |
Outcome results
Primary
Diagnostic Accuracy.
Time frame: 36 months
Population: One patient was lost to follow up. Final diagnosis was unconfirmed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quick Core Needle | Diagnostic Accuracy. | 88 Percentage of participants |
| ProCore Needle | Diagnostic Accuracy. | 62 Percentage of participants |
Secondary
Number of Needle Passes
Time frame: 36 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quick Core Needle | Number of Needle Passes | 2.07 Needle passes | Standard Deviation 0.72 |
| ProCore Needle | Number of Needle Passes | 2.14 Needle passes | Standard Deviation 0.95 |
Secondary
Overall Specimen Length
Time frame: 36 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quick Core Needle | Overall Specimen Length | 19.4 mm | Standard Deviation 14.1 |
| ProCore Needle | Overall Specimen Length | 4.3 mm | Standard Deviation 4.5 |