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

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Device: Fine Needle Biopsy (FNB); Device: Fine Needle Aspiration (FNA)

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FNB first, then FNA; 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); 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.; Other Names: Shark Core Fine Needle Biopsy; Device: Fine Needle Aspiration (FNA); 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.
Active Comparator: FNA first, then FNB; 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); 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.; Other Names: Shark Core Fine Needle Biopsy; Device: Fine Needle Aspiration (FNA); 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Medtronic
• Investigators: Principal Investigator: Michael B. Wallace, MD, MPH, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: May 16, 2016
• Primary Completion (Actual): November 10, 2018
• Study Completion (Actual): November 10, 2018

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 15-007801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No