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

NCT02872831 | Withdrawn DMC

• 1 other identifier: 15G.533
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Lymphadenopathy; Cholangiocarcinoma

Keywords

Fine needle aspiration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sensitivity of the EUS Needles

  12 months

• Complications of the EUS Needles

  12 months

• Diagnostic sufficiency of Tissue obtained by 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.

  12 months

Study Arms (2)

22G SharkCore™ needle

ACTIVE COMPARATOR

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

Device: 22G SharkCore™ needle

22G BNX EUS-FNA needle

ACTIVE COMPARATOR

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

Interventions

22G SharkCore™ needle DEVICE

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 SharkCore™ needle

22G BNX EUS-FNA Needle DEVICE

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.

22G BNX EUS-FNA needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Refusal to participate in the study
• Solid-appearing mass lesion that in not amenable to EUS guided needle access for tissue acquisition
• Patients with incomplete medical records
• Pregnant patients
• Prisoners
• INR \> 1.5
• Platelets \< 50,000

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Lymphadenopathy; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Ali Siddiqui, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 19, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)