An interventional study of Fine Needle Biopsy (FNB) and Fine Needle Aspiration (FNA) in Pancreatic Cancer, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-01-06.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic
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.
This is a single-blinded randomized controlled trial with paired evaluation of conventional FNA needle versus FNB needle stratified by lesion location (pancreas head tumor versus pancreas body/tail). A minimum of 4 passes ( 2 with each needle) will be performed from all the lesions. After each pass of needle, the on-site cytopathologists will evaluate the adequacy and the degree of the pathological changes in the obtained material. Based on the information provided by the onsite cytopathologists, the endosonographer will repeat the FNA until enough histological material is obtained to confirm a diagnosis. Patients will be assessed immediately after procedure and during the first 30 days with a follow-up.
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This study's enrollment of 50 is close to the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.
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In an endoscopic ultrasound-guided procedure, Shark Core Fine Needle Biopsy (FNB) will be performed first, followed by Fine Needle Aspiration (FNA).
Device: Fine Needle Biopsy (FNB) · Device: Fine Needle Aspiration (FNA)
In an endoscopic ultrasound-guided procedure, Fine Needle Aspiration (FNA) will be performed first, followed by Shark Core Fine Needle Biopsy (FNB).
Device: Fine Needle Biopsy (FNB) · Device: Fine Needle Aspiration (FNA)
The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.
Also known as: Shark Core Fine Needle Biopsy
Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds.
Total DNA Yield of Adenocarcinoma
Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.
Time frame: Baseline
Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis
The total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation.
Time frame: Baseline
Core Tissue Length
The length of the tissue core sample acquired, on the first needle pass, measured in centimeters.
Time frame: Baseline
Concentration of DNA Yield of Adenocarcinoma
The concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter.
Time frame: Baseline
Percentage of Tumor Cellularity
Percent of tumor cellularity with first pass of adenocarcinoma
Time frame: Baseline
Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation
The total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist.
Time frame: Baseline
Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation
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.
Time frame: Baseline
| Milestone | FNB First, Then FNA | FNA First, Then FNB |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 25 |
| Not completed | 0 | 0 |
| Milestone | FNB First, Then FNA | FNA First, Then FNB |
|---|---|---|
| Started | 25 | 25 |
| Completed | 23 | 23 |
| Not completed | 2 | 2 |
Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.
| ng/µL | Fine Needle Biopsy (FNB) | Fine Needle Aspiration (FNA) |
|---|---|---|
| Total DNA Yield of Adenocarcinoma | 5930.10 ± 881 | 3365.22 ± 788 |
The total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation.
| needle passes | Fine Needle Biopsy (FNB) | Fine Needle Aspiration (FNA) |
|---|---|---|
| Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis | 5 (0 to 5) | 2 (0 to 5) |
The length of the tissue core sample acquired, on the first needle pass, measured in centimeters.
| centimeters | Fine Needle Biopsy (FNB) | Fine Needle Aspiration (FNA) |
|---|---|---|
| Core Tissue Length | 6 (0 to 20) | 2 (0 to 7) |
The concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter.
| µg/mL | Fine Needle Biopsy (FNB) | Fine Needle Aspiration (FNA) |
|---|---|---|
| Concentration of DNA Yield of Adenocarcinoma | 65.00 ± 8.6 | 37.21 ± 8.3 |
Percent of tumor cellularity with first pass of adenocarcinoma
| percentage of tumor cellularity | Fine Needle Biopsy (FNB) | Fine Needle Aspiration (FNA) |
|---|---|---|
| Percentage of Tumor Cellularity | 40 (0 to 90) | 10 (0 to 100) |
The total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist.
| Participants | Fine Needle Biopsy (FNB) | Fine Needle Aspiration (FNA) |
|---|---|---|
| Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation | 3 | 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.
| Participants | Fine Needle Biopsy (FNB) | Fine Needle Aspiration (FNA) |
|---|---|---|
| Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation | 33 | 4 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fine Needle Biopsy (FNB) | 0/50 (0%) | 0/50 (0%) | 2/50 (4%) |
| Fine Needle Aspiration (FNA) | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Event | Fine Needle Biopsy (FNB) | Fine Needle Aspiration (FNA) |
|---|---|---|
| PancreatitisGeneral disorders | 2/50 | 0/50 |
| Age, Continuous(years) | FNB First, Then FNA | FNA First, Then FNB | Total |
|---|---|---|---|
| Mean | 67 ± 14.1 | 70 ± 9.0 | 69 ± 11.8 |
| Sex: Female, Male(Participants) | FNB First, Then FNA | FNA First, Then FNB | Total |
|---|---|---|---|
| Female | 12 | 12 | 24 |
| Male | 13 | 13 | 26 |
| Race (NIH/OMB)(Participants) | FNB First, Then FNA | FNA First, Then FNB | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 3 | 4 |
| White | 22 | 22 | 44 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | FNB First, Then FNA | FNA First, Then FNB | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
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