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Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle
NA trial testing Fine Needle Biopsy (FNB) in Pancreatic Cancer in 50 participants. Completed in 10 November 2018.
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 50 |
| Start date | 16 May 2016 |
| Primary completion | 10 November 2018 |
| Estimated completion | 10 November 2018 |
| Sites | 1 location across United States |
Mayo Clinic
Adults 18 to 100, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.
| Group | Value | 95% CI |
|---|---|---|
| Fine Needle Biopsy (FNB) | 5930.10 | ± 881 |
| Fine Needle Aspiration (FNA) | 3365.22 | ± 788 |
The total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation.
| Group | Value | 95% CI |
|---|---|---|
| Fine Needle Biopsy (FNB) | 5 | 0 – 5 |
| Fine Needle Aspiration (FNA) | 2 | 0 – 5 |
The length of the tissue core sample acquired, on the first needle pass, measured in centimeters.
| Group | Value | 95% CI |
|---|---|---|
| Fine Needle Biopsy (FNB) | 6 | 0 – 20 |
| Fine Needle Aspiration (FNA) | 2 | 0 – 7 |
The concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter.
| Group | Value | 95% CI |
|---|---|---|
| Fine Needle Biopsy (FNB) | 65.00 | ± 8.6 |
| Fine Needle Aspiration (FNA) | 37.21 | ± 8.3 |
Percent of tumor cellularity with first pass of adenocarcinoma
| Group | Value | 95% CI |
|---|---|---|
| Fine Needle Biopsy (FNB) | 40 | 0 – 90 |
| Fine Needle Aspiration (FNA) | 10 | 0 – 100 |
The total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist.
| Group | Value | 95% CI |
|---|---|---|
| Fine Needle Biopsy (FNB) | 3 | |
| Fine Needle Aspiration (FNA) | 18 |
The number of subjects whose first pass biopsy contained adequate material for high quality histologic interpretation, as determined by a cytopathologist. High quality is defined as being greater than 10 power field in length.
| Group | Value | 95% CI |
|---|---|---|
| Fine Needle Biopsy (FNB) | 33 | |
| Fine Needle Aspiration (FNA) | 4 |
Time frame: Adverse events were assessed immediately after the procedure and during the first 30 days with a follow-up telephone call or clinical visit for each subject, for a total of approximately two and a half years.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Fine Needle Biopsy (FNB) | Fine Needle Aspiration (FNA) |
|---|---|---|---|
| Pancreatitis | General disorders | — | — |
Data from ClinicalTrials.gov NCT02678442 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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