N/A
Completed N=60
Comparison of a Novel 22-gauge Core Biopsy Needle
Solid Pancreatic Mass Lesions · Pancreatic Cancer
Source: ClinicalTrials.gov NCT01598194 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Comparison of Diagnostic Adequacy Scores With SST vs. CST for Cytologic Diagnosis Using a 22G Core Needle. — 5; 6; 24; 24 Participants
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.
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 | — |
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. Informational only — not medical advice.