N/A
N=60
Comparison of a Novel 22-gauge Core Biopsy Needle
Solid Pancreatic Mass Lesions · Malignant Neoplasm of Pancreas
Bottom Line
View on ClinicalTrials.gov: NCT01598194 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle. — 5; 6; 24; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Novel 22-gauge Core Biopsy Needle + Standard Biopsy Needle (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle. |
5; 6; 24; 24; 23; 21 | — |
| PRIMARY Comparison of Diagnostic Adequacy Scores With SST vs. CST for Histologic Diagnosis Using a 22G Core Needle. |
8; 9; 19; 20; 5; 8 | — |
| SECONDARY Comparison of Diagnostic Adequacy of Single Pass With 22G Core Needle and Standard 25G Needle for Cytologic Diagnosis |
48; 57; 44; 45; 36; 43 | — |
Summary
The goal of this clinical research study is to compare the performance of a newly available needle with reverse bevel design (called the EchoTip® Procore™ needle) with standard needles to see which needle gives better diagnostic information for pancreatic lesions.
Eligibility Criteria
Inclusion Criteria
- Patient age 18 years and older.
- All patients referred for EUS FNA of endoscopically accessible solid pancreatic lesions.
Exclusion Criteria
- Unable to obtain informed consent.
- Unable to tolerate the procedure.
- Women with known pregnancy at time.
- Patient age less than 18 years of age.
- Bleeding diathesis
- Cystic pancreatic lesions
- Lesion not accessible by EUS guided FNA
Data sourced from ClinicalTrials.gov (NCT01598194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.