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

Not Applicable

Completed

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Total DNA Yield of Adenocarcinoma	Baseline	Total quantity of DNA obtained from first needle pass of adenocarcinoma, measured in ng/µL.

Secondary Outcome Measures

Name	Time	Method
Percentage of Tumor Cellularity	Baseline	Percent of tumor cellularity with first pass of adenocarcinoma
Total Number of Passes Needed to Obtain Adequate Tissue Sample for Cytology/Histology Diagnosis	Baseline	The total number of passes required to obtain adequate tissue sample for cytology/histology processing and interpretation.
Concentration of DNA Yield of Adenocarcinoma	Baseline	The concentration of the DNA from the adenocarcinoma on the first needle pass, measured in micrograms per microliter.
Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for Cytologic Interpretation	Baseline	The total number of subjects whose first-pass biopsy contained adequate material for cytologic interpretation, as determined by a cytopathologist.
Total Number of Subjects Where First-pass Biopsy Contained Adequate Material for High Quality Histologic Interpretation	Baseline	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.
Core Tissue Length	Baseline	The length of the tissue core sample acquired, on the first needle pass, measured in centimeters.