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

Study Overview

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

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.

Pancreatic Cancer

DEVICE: Fine Needle Biopsy (FNB)
DEVICE: Fine Needle Aspiration (FNA)

15-007801

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-02-05	Results First Submitted 2019-12-05	Last Update Submitted that met QC Criteria 2019-12-17
First Submitted that Met QC Criteria 2016-02-08	Results First Submitted that Met QC Criteria 2019-12-17	Last Update Posted (ACTUAL) 2020-01-06
First Posted (ACTUAL) 2016-02-09	Results First Posted 2020-01-06	Last Verified 2019-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Randomized

Interventional Model:
Crossover

Masking:
Single

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. 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
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. 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

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.

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

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.

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

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Medical condition that preclude the patient from having a therapeutic procedure regardless of the EUS finding
Pregnant patients

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Medtronic

Investigators

PRINCIPAL_INVESTIGATOR: Michael B. Wallace, MD, MPH, Mayo Clinic

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record