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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
50
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.
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.
Mayo Clinic
Jacksonville, Florida, United States
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.
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Time frame: Baseline