Brief Title
Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle
Official Title
Prospective Randomized Study of Utilizing the 22-gauge Standard FNA Needle Compared to the SharkCore™ 22-gauge Fine Needle Biopsy (FNB) Needle in Patients With Solid Mass Lesions of the Gastrointestinal Tract
Brief Summary
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.
Detailed Description
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.
Study Type
Interventional
Primary Outcome
Diagnostic Accuracy of the 22G SharkCore™ and the 22G BNX EUS-FNA needle
Secondary Outcome
Sensitivity of the EUS Needles
Condition
Pancreatic Cancer
Intervention
22G SharkCore™ needle
Study Arms / Comparison Groups
22G SharkCore™ needle
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
376
Start Date
July 2016
Completion Date
November 2017
Primary Completion Date
July 2017
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
1. Refusal to participate in the study
2. Solid-appearing mass lesion that in not amenable to EUS guided needle access for
tissue acquisition
3. Patients with incomplete medical records
4. Pregnant patients
5. Prisoners
6. INR > 1.5
7. Platelets < 50,000
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Ali Siddiqui, MD, 2159558900, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02872831
Organization ID
15G.533
Responsible Party
Sponsor
Study Sponsor
Thomas Jefferson University
Study Sponsor
Ali Siddiqui, MD, Principal Investigator, Thomas Jefferson University
Verification Date
October 2016