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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02872831
• Other study ID #: 15G.533
• Status: Terminated
• Phase: N/A
• Start date: July 2016
• Est. completion date: November 2017

Study information

• Verified date: February 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 376
• Est. completion date: November 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Lymphadenopathy
• Pancreatic Cancer

Intervention

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 be evaluated by one pathologist, who was blinded to the randomization sequence, for the presence of a histologic tissue. If adequate histologic tissue is present, the specimen will be graded as optimal or suboptimal.
• 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 into Hanks's solution and sent for cell block processing. The cytology technician or cytopathologist on site will verify adequacy of specimens. At least two passes will be obtained from the lesion unless the technician established the presence of malignant appearing cells.

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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