Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot-Feasibility Trial of EUS Guided Pancreas Fine Needle Core Biopsy for Whole Exome Sequencing and Genomic Profiling

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Device: Fine Needle Biopsy (FNB)
* Device: Fine Needle Aspiration (FNA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FNB first, then FNA<br>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)<br>* 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.<br>* Other names: Shark Core Fine Needle Biopsy;Device: Fine Needle Aspiration (FNA)<br>* 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.<br>|
| Active Comparator: FNA first, then FNB<br>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)<br>* 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.<br>* Other names: Shark Core Fine Needle Biopsy;Device: Fine Needle Aspiration (FNA)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total DNA Yield of Adenocarcinoma | Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline | 
| Core Tissue Length | The length of the tissue core sample acquired, on the first needle pass, measured in centimeters. | 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. | Baseline | 
| Percentage of Tumor Cellularity | Percent of tumor cellularity with first pass of adenocarcinoma | 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. | 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. | Baseline |