N/A
N=56
22G FNA Needle vs. 22G ProCore Needle
Pancreatic Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT01394159 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Compare the Median Number of Passes Required to Establish a Diagnosis — 1; 1 No. of passes for diagnosis
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 22G ProCore biopsy needle (Procedure); 22G standard FNA needle (Procedure)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- AdventHealth
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Compare the Median Number of Passes Required to Establish a Diagnosis |
1; 1 | — |
| SECONDARY Diagnosis Achieved With the Needle |
25; 28 | — |
| SECONDARY Technical Failure |
1; 0 | — |
Summary
The aim of this research study is to identify the best needle for performing biopsy during EUS procedures. There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a 22G ProCore needle that provides larger amount of tissue. It is not clear at this point which of the two needles is superior for performing biopsy. This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.
Eligibility Criteria
Inclusion Criteria
-All patients with solid pancreatic mass lesions
Exclusion Criteria
- Coaguloapthy,
- minors,
- prgenant patients
Data sourced from ClinicalTrials.gov (NCT01394159). 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.