N/A
N=50
Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02678442 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Total DNA Yield of Adenocarcinoma — 5930.10; 3365.22 ng/µL — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fine Needle Biopsy (FNB) (Device); Fine Needle Aspiration (FNA) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total DNA Yield of Adenocarcinoma |
5930.10; 3365.22 | 0.01 sig |
| SECONDARY Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis |
5; 2 | — |
| SECONDARY Core Tissue Length |
6; 2 | 0.001 sig |
| SECONDARY Concentration of DNA Yield of Adenocarcinoma |
65.00; 37.21 | 0.02 sig |
| SECONDARY Percentage of Tumor Cellularity |
40; 10 | .001 sig |
| SECONDARY Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation |
3; 18 | — |
| SECONDARY Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation |
33; 4 | — |
Summary
This is a clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.
Eligibility Criteria
Inclusion Criteria
- Male and female patients who are 18 years old or older and are referred for the evaluation of pancreatic mass lesion.
- International Normalized Ratio (INR) less than 1.5 and platelet count of more than 50,000.
- Medically stable to undergo sedation for EUS.
- Signed informed consent
Exclusion Criteria
- Medical condition that preclude the patient from having a therapeutic procedure regardless of the EUS finding
- Pregnant patients
Data sourced from ClinicalTrials.gov (NCT02678442). 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.