Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle Vs SharkCore™ Needle

Study Overview

Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle

The primary objective of this proposed prospective randomized, multi-center study is to evaluate the capability of the new 22G SharkCore™ needle to obtain tissue specimens and to compare its performance against the standard 22G BNX Endoscopic Ultrasound Fine needle aspiration (Beacon Endoscopic, Newton, MA) needle in the evaluation of solid mass lesions in the pancreas and gastrointestinal tract. The secondary objective is to determine the ability of the 22G SharkCore™ needle system to yield histologic tissue.

Rationale: A tissue core biopsy with preserved architecture is critical to diagnose and fully characterize certain neoplasms, such as lymphomas and GI stromal tumors (GIST). Moreover, tissue specimens for histologic examination also provides the opportunity to immunostain the tissue, further increasing differential diagnostic capabilities; reach a specific diagnosis for benign diseases not always obtainable with a cytological sample, thus sparing patients from more invasive and risky sampling procedures or costly and unnecessary follow-up examinations; perform tissue profiling and/or cell culture needed to guide targeted therapies for individualized treatment of patients with cancer of the GI tract. There has previously been no needle available on the market that can accurately and consistently acquire EUS-guided histologic tissue from solid gastrointestinal lesions. Covidien has recently released a novel SharkCore™ Fine Needle Biopsy (FNB) system for EUS-guided tissue acquisition of solid gastrointestinal lesions. With its unique bevel design, this needle has shown promising results to acquire histologic tissue as per oral communication with physicians around the country (Douglas Adler and Christopher DiMaio). Currently, there is no published clinical data on the capability of the SharkCore™ needle to obtain specimens via EUS guidance. The rationale of the currently proposed trial is to assess the operating characteristics SharkCore™ needle system and to determine the ability of this needle system to yield histologic tissue. Medtronic Inc. has provided us with an unrestricted grant in order to evaluate the capability of the new 22G SharkCore™ needle to obtain tissue specimens and to compare its performance against the standard 22G BNX EUS-FNA. Primary Objectives The primary objective of this proposed prospective randomized, multi-center study is to evaluate the capability of the new 22G SharkCore™ needle to obtain tissue specimens and to compare its performance against the standard 22G BNX Endoscopic Ultrasound Fine needle aspiration (Beacon Endoscopic, Newton, MA) needle in the evaluation of solid mass lesions in the pancreas and gastrointestinal tract. The secondary objective is to determine the ability of the 22G SharkCore™ needle system to yield histologic tissue. Study Design We propose a prospective comparative study (22G SharkCore™ needle versus the 22G BNX EUS-FNA needle) randomized (randomization of the order of the needles) in crossover (on the same lesion) in samples of solid pancreatic and gastrointestinal tumors. Up to 6 sites in the United States will enroll the patients. The respective institutional investigators will review serious adverse events throughout the study. No interim analysis is planned.

Pancreatic Cancer
Lymphadenopathy
Cholangiocarcinoma

DEVICE: 22G SharkCore™ needle
DEVICE: 22G BNX EUS-FNA Needle

15G.533

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 2016-07-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-02-20
First Submitted that Met QC Criteria 2016-08-15	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-02-22
First Posted (ACTUAL) 2016-08-19	Results First Posted N/A	Last Verified 2024-02

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:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Single

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: 22G SharkCore™ needle Covidien has recently released a novel SharkCore™ Fine Needle Biopsy (FNB) system for EUS-guided tissue acquisition of solid gastrointestinal lesions. With its unique bevel design, this needle has shown promising results to acquire histologic tissue as pe	DEVICE: 22G SharkCore™ needle The 2 dedicated passes from the SharkCore™ needle will be placed in a jar with formaldehyde-based fixative and sent for routine histopathology evaluation. The cassette will be processed, embedded in paraffin, and then prepared in hematoxylin and eosin to
ACTIVE_COMPARATOR: 22G BNX EUS-FNA needle The standard 22G BNX Endoscopic Ultrasound Fine needle aspiration (Beacon Endoscopic, Newton, MA) needle is routinely used for the evaluation of solid mass lesions in the pancreas and gastrointestinal tract.	DEVICE: 22G BNX EUS-FNA Needle Aspirates will be placed onto glass slides and preserved with Diff-Quik stain (American Scientific Products, McGraw Park, Illinois, USA). In addition, a smear will also be placed in alcohol for Papanicolaou staining. Any additional material was sprayed in

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: 22G SharkCore™ needle

Covidien has recently released a novel SharkCore™ Fine Needle Biopsy (FNB) system for EUS-guided tissue acquisition of solid gastrointestinal lesions. With its unique bevel design, this needle has shown promising results to acquire histologic tissue as pe

DEVICE: 22G SharkCore™ needle

The 2 dedicated passes from the SharkCore™ needle will be placed in a jar with formaldehyde-based fixative and sent for routine histopathology evaluation. The cassette will be processed, embedded in paraffin, and then prepared in hematoxylin and eosin to

ACTIVE_COMPARATOR: 22G BNX EUS-FNA needle

The standard 22G BNX Endoscopic Ultrasound Fine needle aspiration (Beacon Endoscopic, Newton, MA) needle is routinely used for the evaluation of solid mass lesions in the pancreas and gastrointestinal tract.

DEVICE: 22G BNX EUS-FNA Needle

Aspirates will be placed onto glass slides and preserved with Diff-Quik stain (American Scientific Products, McGraw Park, Illinois, USA). In addition, a smear will also be placed in alcohol for Papanicolaou staining. Any additional material was sprayed in

Primary Outcome Measures	Measure Description	Time Frame
Diagnostic Accuracy of the 22G SharkCore™ and the 22G BNX EUS-FNA needle	The primary endpoint measures of the study is to evaluate the diagnostic accuracy of the 22G SharkCore™ needle system or the 22G BNX EUS-FNA needle for the diagnosis malignancy in solid lesions of the pancreas and gastrointestinal tract. Diagnostic accuracy of the EUS needles for the diagnosis of malignancy is calculated as the number of True Positives with malignancy +True Negatives with malignancy/True Positives with malignancy +True Negatives with malignancy +False Positives with malignancy +False Negatives with malignancy.	12 months

Secondary Outcome Measures	Measure Description	Time Frame
Sensitivity of the EUS Needles	Sensitivity is expressed in percentage and defines the proportion of true positive subjects with malignancy in a total group of subjects with malignancy.	12 months
Complications of the EUS Needles	Complications will be defined as any deviation from the clinical course after EUS-guided sampling as observed by the endosonographer or recovery suite nurse or as reported by patients. Excessive bleeding at the site of puncture, perforation, hypotension, and need for reversal medication will be documented.	12 months
Diagnostic sufficiency of Tissue obtained by the EUS Needles	Diagnostic sufficiency is defined as the proportion of patients in whom an on-site diagnosis was established within 2 passes of the EUS needles	12 months
Specificity of the 22G SharkCore™ needle and the 22G BNX EUS-FNA Needle for the diagnosis malignancy in solid lesions of the pancreas and gastrointestinal tract.	Specificity is defined as a proportion of subjects without the malignancy with negative test result in total of subjects without malignancy	12 months

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:
1

Eligible patients will include anyone >18 years old that presents to the participating clinical institutions and requires an endosonographic evaluation for the presence of a solid-appearing mass lesion amenable to EUS access, and no contraindication to FNA as determined by standard clinical care

Collaborators and Investigators

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

Investigators

PRINCIPAL_INVESTIGATOR: Ali Siddiqui, MD, Thomas Jefferson University

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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